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. 2022 Aug 24;8(8):CD012396.
doi: 10.1002/14651858.CD012396.pub2.

Luteal phase support for women trying to conceive by intrauterine insemination or sexual intercourse

Lingling Salang  1 , Danielle M Teixeira  2 , Ivan Solà  3 , Jen Sothornwit  1 , Wellington P Martins  4 , Magdalena Bofill Rodriguez  5 , Pisake Lumbiganon  1
Affiliations

Luteal phase support for women trying to conceive by intrauterine insemination or sexual intercourse

Lingling Salang et al. Cochrane Database Syst Rev. .

Abstract

Background: Ovulation induction may impact endometrial receptivity due to insufficient progesterone secretion. Low progesterone is associated with poor pregnancy outcomes.

Objectives: To assess the effectiveness and safety of luteal phase support (LPS) in infertile women trying to conceive by intrauterine insemination or by sexual intercourse.

Search methods: We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, LILACS, trial registries for ongoing trials, and reference lists of articles (from inception to 25 August 2021).

Selection criteria: Randomised controlled trials (RCTs) of LPS using progestogen, human chorionic gonadotropin (hCG), or gonadotropin-releasing hormone (GnRH) agonist supplementation in IUI or natural cycle.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. Our primary outcomes were live birth rate/ongoing pregnancy rate (LBR/OPR) and miscarriage. MAIN RESULTS: We included 25 RCTs (5111 participants). Most studies were at unclear or high risk of bias. We graded the certainty of evidence as very low to low. The main limitations of the evidence were poor reporting and imprecision. 1. Progesterone supplement versus placebo or no treatment We are uncertain if vaginal progesterone increases LBR/OPR (risk ratio (RR) 1.10, 95% confidence interval (CI) 0.81 to 1.48; 7 RCTs; 1792 participants; low-certainty evidence) or decreases miscarriage per pregnancy compared to placebo or no treatment (RR 0.70, 95% CI 0.40 to 1.25; 5 RCTs; 261 participants). There were no data on LBR or miscarriage with oral stimulation. We are uncertain if progesterone increases LBR/OPR in women with gonadotropin stimulation (RR 1.24, 95% CI 0.80 to 1.92; 4 RCTs; 1054 participants; low-certainty evidence) and oral stimulation (clomiphene citrate or letrozole) (RR 0.97, 95% CI 0.58 to 1.64; 2 RCTs; 485 participants; low-certainty evidence). One study reported on OPR in women with gonadotropin plus oral stimulation; the evidence from this study was uncertain (RR 0.73, 95% CI 0.37 to 1.42; 1 RCT; 253 participants; low-certainty evidence). Given the low certainty of the evidence, it is unclear if progesterone reduces miscarriage per clinical pregnancy in any stimulation protocol (RR 0.68, 95% CI 0.24 to 1.91; 2 RCTs; 102 participants, with gonadotropin; RR 0.67, 95% CI 0.30 to 1.50; 2 RCTs; 123 participants, with gonadotropin plus oral stimulation; and RR 0.53, 95% CI 0.25 to 1.14; 2 RCTs; 119 participants, with oral stimulation). Low-certainty evidence suggests that progesterone in all types of ovarian stimulation may increase clinical pregnancy compared to placebo (RR 1.38, 95% CI 1.10 to 1.74; 7 RCTs; 1437 participants, with gonadotropin; RR 1.40, 95% CI 1.03 to 1.90; 4 RCTs; 733 participants, with gonadotropin plus oral stimulation (clomiphene citrate or letrozole); and RR 1.44, 95% CI 1.04 to 1.98; 6 RCTs; 1073 participants, with oral stimulation). 2. Progesterone supplementation regimen We are uncertain if there is any difference between 300 mg and 600 mg of vaginal progesterone for OPR and multiple pregnancy (RR 1.58, 95% CI 0.81 to 3.09; 1 RCT; 200 participants; very low-certainty evidence; and RR 0.50, 95% CI 0.05 to 5.43; 1 RCT; 200 participants, very low-certainty evidence, respectively). No other outcomes were reported for this comparison. There were three different comparisons between progesterone regimens. For OPR, the evidence is very uncertain for intramuscular (IM) versus vaginal progesterone (RR 0.59, 95% CI 0.34 to 1.02; 1 RCT; 225 participants; very low-certainty evidence); we are uncertain if there is any difference between oral and vaginal progesterone (RR 1.25, 95% CI 0.70 to 2.22; 1 RCT; 150 participants; very low-certainty evidence) or between subcutaneous and vaginal progesterone (RR 1.05, 95% CI 0.54 to 2.05; 1 RCT; 246 participants; very low-certainty evidence). We are uncertain if IM or oral progesterone reduces miscarriage per clinical pregnancy compared to vaginal progesterone (RR 0.75, 95% CI 0.43 to 1.32; 1 RCT; 81 participants and RR 0.58, 95% CI 0.11 to 3.09; 1 RCT; 41 participants, respectively). Clinical pregnancy and multiple pregnancy were reported for all comparisons; the evidence for these outcomes was very uncertain. Only one RCT reported adverse effects. We are uncertain if IM route increases the risk of adverse effects when compared with the vaginal route (RR 9.25, 95% CI 2.21 to 38.78; 1 RCT; 225 participants; very low-certainty evidence). 3. GnRH agonist versus placebo or no treatment No trials reported live birth. The evidence is very uncertain about the effect of GnRH agonist in ongoing pregnancy (RR 1.10, 95% CI 0.70 to 1.74; 1 RCT; 291 participants, very low-certainty evidence), miscarriage per clinical pregnancy (RR 0.73, 95% CI 0.26 to 2.10; 2 RCTs; 79 participants, very low-certainty evidence) and clinical pregnancy (RR 1.00, 95% CI 0.68 to 1.47; 2 RCTs; 340 participants; very low-certainty evidence), and multiple pregnancy (RR 0.28, 95% CI 0.11 to 0.70; 2 RCTs; 126 participants). 4. GnRH agonist versus vaginal progesterone The evidence for the effect of GnRH agonist injection on clinical pregnancy is very uncertain (RR 1.00, 95% CI 0.51 to 1.95; 1 RCT; 242 participants). 5. HCG injection versus no treatment The evidence for the effect of hCG injection on clinical pregnancy (RR 0.93, 95% CI 0.40 to 2.13; 1 RCT; 130 participants) and multiple pregnancy rates (RR 1.03, 95% CI 0.22 to 4.92; 1 RCT; 130 participants) is very uncertain. 6. Luteal support in natural cycle No study evaluated the effect of LPS in natural cycle. We could not perform sensitivity analyses, as there were no studies at low risk of selection bias and not at high risk in other domains.

Authors' conclusions: We are uncertain if vaginal progesterone supplementation during luteal phase is associated with a higher live birth/ongoing pregnancy rate. Vaginal progesterone may increase clinical pregnancy rate; however, its effect on miscarriage rate and multiple pregnancy rate is uncertain. We are uncertain if IM progesterone improves ongoing pregnancy rates or decreases miscarriage rate when compared to vaginal progesterone. Regarding the other reported comparisons, neither oral progesterone nor any other medication appears to be associated with an improvement in pregnancy outcomes (very low-certainty evidence).

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Conflict of interest statement

LS declares no conflict of interest.

DMT declares no conflict of interest.

IS declares no conflict of interest.

JS declares no conflict of interest.

WPM declares no conflict of interest.

MBR declares no conflict of interest.

PL declares no conflict of interest.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1: Progesterone versus no treatment or placebo (route of progesterone administration), Outcome 1: Live birth/ongoing pregnancy rate
1.2
1.2. Analysis
Comparison 1: Progesterone versus no treatment or placebo (route of progesterone administration), Outcome 2: Miscarriage per clinical pregnancy
1.3
1.3. Analysis
Comparison 1: Progesterone versus no treatment or placebo (route of progesterone administration), Outcome 3: Miscarriage per woman
1.4
1.4. Analysis
Comparison 1: Progesterone versus no treatment or placebo (route of progesterone administration), Outcome 4: Clinical pregnancy per woman
1.5
1.5. Analysis
Comparison 1: Progesterone versus no treatment or placebo (route of progesterone administration), Outcome 5: Multiple pregnancy per woman
2.1
2.1. Analysis
Comparison 2: Progesterone versus no treatment or placebo (type of ovarian stimulation), Outcome 1: Live birth/ongoing pregnancy rate
2.2
2.2. Analysis
Comparison 2: Progesterone versus no treatment or placebo (type of ovarian stimulation), Outcome 2: Miscarriage per clinical pregnancy
2.3
2.3. Analysis
Comparison 2: Progesterone versus no treatment or placebo (type of ovarian stimulation), Outcome 3: Miscarriage per woman
2.4
2.4. Analysis
Comparison 2: Progesterone versus no treatment or placebo (type of ovarian stimulation), Outcome 4: Clinical pregnancy per woman
2.5
2.5. Analysis
Comparison 2: Progesterone versus no treatment or placebo (type of ovarian stimulation), Outcome 5: Multiple pregnancy per woman
3.1
3.1. Analysis
Comparison 3: 300 mg vaginal progesterone versus 600 mg vaginal progesterone, Outcome 1: Ongoing pregnancy per woman
3.2
3.2. Analysis
Comparison 3: 300 mg vaginal progesterone versus 600 mg vaginal progesterone, Outcome 2: Multiple pregnancy per woman
4.1
4.1. Analysis
Comparison 4: IM progesterone versus vaginal progesterone, Outcome 1: Ongoing pregnancy per woman
4.2
4.2. Analysis
Comparison 4: IM progesterone versus vaginal progesterone, Outcome 2: Miscarriage per clinical pregnancy
4.3
4.3. Analysis
Comparison 4: IM progesterone versus vaginal progesterone, Outcome 3: Miscarriage per woman
4.4
4.4. Analysis
Comparison 4: IM progesterone versus vaginal progesterone, Outcome 4: Clinical pregnancy per woman
4.5
4.5. Analysis
Comparison 4: IM progesterone versus vaginal progesterone, Outcome 5: Adverse effect
5.1
5.1. Analysis
Comparison 5: Oral progesterone versus vaginal progesterone, Outcome 1: Ongoing pregnancy per woman
5.2
5.2. Analysis
Comparison 5: Oral progesterone versus vaginal progesterone, Outcome 2: Miscarriage per clinical pregnancy
5.3
5.3. Analysis
Comparison 5: Oral progesterone versus vaginal progesterone, Outcome 3: Miscarriage per woman
5.4
5.4. Analysis
Comparison 5: Oral progesterone versus vaginal progesterone, Outcome 4: Clinical pregnancy per woman
6.1
6.1. Analysis
Comparison 6: Aqueous Sc progesterone versus vaginal progesterone gel, Outcome 1: Ongoing pregnancy per woman
6.2
6.2. Analysis
Comparison 6: Aqueous Sc progesterone versus vaginal progesterone gel, Outcome 2: Clinical pregnancy per woman
7.1
7.1. Analysis
Comparison 7: Sc GnRH agonist versus no treatment or placebo, Outcome 1: Ongoing pregnancy per woman
7.2
7.2. Analysis
Comparison 7: Sc GnRH agonist versus no treatment or placebo, Outcome 2: Miscarriage per clinical pregnancy
7.3
7.3. Analysis
Comparison 7: Sc GnRH agonist versus no treatment or placebo, Outcome 3: Miscarriage per woman
7.4
7.4. Analysis
Comparison 7: Sc GnRH agonist versus no treatment or placebo, Outcome 4: Clinical pregnancy per woman
7.5
7.5. Analysis
Comparison 7: Sc GnRH agonist versus no treatment or placebo, Outcome 5: Multiple pregnancy per woman
8.1
8.1. Analysis
Comparison 8: Vaginal progesterone versus GnRH agonist, Outcome 1: Clinical pregnancy per woman
9.1
9.1. Analysis
Comparison 9: HCG injection versus no treatment, Outcome 1: Clinical pregnancy per woman
9.2
9.2. Analysis
Comparison 9: HCG injection versus no treatment, Outcome 2: Multiple pregnancy per woman
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References

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Lebrocquy 1998 {published data only}
    1. Lebrocquy C, Geriil A, Janssen J, Evenepoel J, Branden K. Results of an artificial insemination programme with cryopreserved donor spermatozoa with or without luteal supplementation in cycles with clomiphene citrate. Human Reproduction 1998;13(1):19.
Ludwig 2001 {published data only}
    1. Ludwig M, Finas A, Katalinic A, Strik D, Kowalcek I, Schwartz P, et al. Prospective, randomised study to evaluate the pregnancy rate using HCG, vaginal progesterone (Utrogest), or a combination of both for luteal-phase support: preliminary results. Acta Obstetricia et Gynecologica Scandinavica 2001;80(1):574-82. - PubMed
Madkour 2016 {unpublished data only}
    1. Madkour WA, Noah B, Arm MS, Hamid A, Zeheer H, Al-Bahr A, et al. Luteal phase support with progesterone versus estrogen and progesterone on pregnancy rates. Human Fertility 2016;19:142-9. - PubMed
Maher 2011 {published data only}
    1. Maher MA. Luteal phase support may improve pregnancy outcomes during intrauterine insemination cycles. European Journal of Obstetrics & Gynecology and Reproductive Biology 2011;157:57-62. - PubMed
Malhotra 2016 {published data only}
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Malik 2016 {published data only}
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Martins 2010 {published data only}
    1. Martins WP. Suporte da fase lútea. Femina 2010;38(5):271-6.
Miralpeix 2014a {published data only}
    1. Miralpeix E, González-Comadran M, Solà I, Manau D, Carreras R, Checa MA. Efficacy of luteal phase support with vaginal progesterone in intrauterine insemination: a systematic review and meta-analysis. Journal of Assisted Reproduction and Genetics 2014;31(1):89-100. - PMC - PubMed
Miralpeix 2016 {published data only}
    1. Miralpeix E, González-Comadran M, Solà I, Manau D, Carreras R, Checa MA. Efficacy of luteal phase support with vaginal progesterone in intrauterine insemination: a systematic review and meta-analysis. Journal of Assisted Reproduction and Genetics 2014;31:89-100. - PMC - PubMed
Mukherjee 2016 {published data only}
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NCT00700492 (a) {published data only}
    1. NCT00700492. Does hormonal luteal support after intra-uterine insemination (IUI) increase the pregnancy rate? www.clinicaltrials.gov/ct2/show/NCT00700492 (first received 18 June 2008).
NCT00700492 (b) {published data only}
    1. NCT00700492. Does hormonal luteal support after intra-uterine insemination (IUI) increase the pregnancy rate? clinicaltrials.gov/ct2/show/NCT00700492 (first received 18 June 2008).
NCT02510534 (a) {published data only}
    1. NCT02510534. Effect of luteal progesterone support on pregnancy rates with combined clomid/ gonadotropin & IUI. clinicaltrials.gov/ct2/show/NCT02510534 (first received 23 September 2016).
NCT02510534 (b) {published data only}
    1. NCT02510534. Effect of luteal progesterone support on pregnancy rates with combined clomid/gonadotropin & IUI. clinicaltrials.gov/ct2/show/NCT02510534 (first received 29 July 2015).
Niles 2019 {published data only}
    1. Niles AM, Fricke HP, Carvalho PD, Wiltbank MC, Hernandez LL, Fricke PM. Effect of treatment with human chorionic gonadotropin 7 days after artificial insemination or at the time of embryo transfer on reproductive outcomes in nulliparous Holstein heifers. Journal of Dairy Science 2019;102(3):2593-606. - PubMed
Ozcimen 2004 {published data only}
    1. Ozcimen E, Ugur M, Ozcimen N, Yilmaz Z. Is luteal phase support with hCG or vaginal micronized progesterone beneficial in non-IVF gonadotropin induction of ovulation? Fertility and Sterility 2004;82(Suppl 2):S142.
Penarrubia 1998 {published data only}
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Pirard 2005 {published data only}
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Schwarze 2013 {published data only}
    1. Schwarze JE, Villa S, Manzur A, Magendzo A, Pommer R. Progesterone-releasing vaginal ring for luteal phase support after superovulation and intrauterine insemination cycles, a pilot study. JBRA Assisted Reproduction 2013;17:313-5.
Tas 2020 {published data only}
    1. Taş M, Uludag SZ, Aygen ME, Sahin Y. Comparison of oral dydrogesterone and vaginal micronized progesterone for luteal phase support in intrauterine insemination. Gynecology Endocrinology 2020;36(1):77-80. - PubMed
    1. Taş M, Uludag SZ, Aygen ME, Sahin Y. Comparison of oral dydrogesterone and vaginal micronized progesterone for luteal phase support in intrauterine insemination. Gynecology Endocrinology 2020;36(1):77-80. - PubMed
Yilmaz 2006 {published data only}
    1. Yilmaz B, Kelekci S, Savan K, Oral H, Mollamahmutoglu L. Addition of human chorionic gonadotropin to clomiphene citrate ovulation induction therapy does not improve pregnancy outcomes and luteal function. Fertility and Sterility 2006;85(3):783-6. - PubMed
Youssef 2000 {published data only}
    1. Youssef G, Maguid A, El-Inany H. Progesterone supplementation in clomiphene citrate treated anovulatory patients with menstrual irregularities: a randomised controlled trial. Middle East Fertility Society Journal 2000;5(3):209-12.
Zaffaroni 1997 {published data only}
    1. Zaffaroni L, Costa P, Vinci G. Topical progesterone as support for the luteal phase in induced cycles. Minerva Gynaecology 1997;49:361-4. - PubMed
Zayed 2003 {published data only}
    1. Zayed FF, El-Jallad MF, Al-Chalabi HA. Luteal phase support in ovarian induction cycles using human chorionic gonadotropin or oral progestogens. Saudi Medical Journal 2003;24(1):34-6. - PubMed

References to studies awaiting assessment

Ebrahimi 2010 {published data only}
    1. Ebrahimi M, Asbagh FA, Darvish S. The effect of luteal phase support on pregnancy rates of the stimulated intrauterine insemination cycles in couples with unexplained infertility. International Journal of Fertility and Sterility 2010;4:51-6.

References to ongoing studies

Maryam 2017 {published data only}
    1. IRCT2017041233379N. The effect of progesterone on pregnancy rates in the intrauterine insemination cycles [The effect of progesterone on pregnancy rates in the intrauterine insemination cycles]. apps.who.int/trialsearch/Trial2.aspx?TrialID=IRCT2017041233379N1 (first received 22 February 2018).
    1. IRCT2017041233379N1. The effect of progesterone on pregnancy rates in the intrauterine insemination cycles [The effect of progesterone suppository to luteal phase support on pregnancy rates in the intrauterine insemination cycles]. apps.who.int/trialsearch/Trial2.aspx?TrialID=IRCT2017041233379N1 (first received 22 February 2018).
NCT03115307 {published data only}
    1. NCT03115307. Luteal phase support in insemination cycles [A protocol for a randomized, controlled study to compare the use of gonodotropin-releasing hormone agonist triptoreline (Gonapeptyl®) for luteal phase support versus natural luteal phase in the insemination cycles]. clinicaltrials.gov/ct2/show/NCT03115307 (first received 14 April 2017).
NCT03440359 {published data only}
    1. NCT03440359. Vaginal progesterone supplementation in women with PCOS undergoing ovulation induction with letrozole [Supplementation of the luteal phase with vaginal progesterone (Crinone 8%) in women with polycystic ovary syndrome undergoing ovulation induction with letrozole: a prospective and randomized controlled trial]. clinicaltrials.gov/ct2/show/NCT03440359 (first received 22 Febuary 2018).

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References to other published versions of this review

Checa 2016
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