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Meta-Analysis
. 2024 Jun 5;6(6):CD009749.
doi: 10.1002/14651858.CD009749.pub3.

Androgens (dehydroepiandrosterone or testosterone) for women undergoing assisted reproduction

Sandeep Naik  1 , Sam Lepine  2 , Helen E Nagels  3 , Charalampos S Siristatidis  4 , Ben Kroon  5   6 , Simon McDowell  1
Affiliations
Meta-Analysis

Androgens (dehydroepiandrosterone or testosterone) for women undergoing assisted reproduction

Sandeep Naik et al. Cochrane Database Syst Rev. .

Abstract

Background: Practitioners in the field of assisted reproductive technology (ART) continually seek alternative or adjunct treatments to improve ART outcomes. This Cochrane review investigates the adjunct use of synthetic versions of two naturally produced hormones, dehydroepiandrosterone (DHEA) and testosterone (T), in assisted reproduction. Steroid hormones are proposed to increase conception rates by positively affecting follicular response to gonadotrophin stimulation. This may lead to a greater oocyte yield and, subsequently, an increased chance of pregnancy.

Objectives: To assess the effectiveness and safety of DHEA and T as pre- or co-treatments in infertile women undergoing assisted reproduction.

Search methods: We searched the following electronic databases up to 8 January 2024: the Gynaecology and Fertility Group (CGF) Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, and trial registries for ongoing trials. We also searched citation indexes, Web of Science, PubMed, and OpenGrey. We searched the reference lists of relevant studies and contacted experts in the field for any additional trials. There were no language restrictions.

Selection criteria: Randomised controlled trials (RCTs) comparing DHEA or T as an adjunct treatment to any other active intervention, placebo, or no treatment in women undergoing assisted reproduction.

Data collection and analysis: Two review authors independently selected studies, extracted relevant data, and assessed risk of bias. We pooled data from studies using fixed-effect models. We calculated odds ratios (ORs) for each dichotomous outcome. Analyses were stratified by type of treatment. We assessed the certainty of evidence for the main findings using GRADE methods.

Main results: We included 28 RCTs. There were 1533 women in the intervention groups and 1469 in the control groups. Apart from three trials, trial participants were women identified as 'poor responders' to standard in vitro fertilisation (IVF) protocols. The included trials compared either T or DHEA treatment with placebo or no treatment. Pre-treatment with DHEA versus placebo/no treatment: DHEA likely results in little to no difference in live birth/ongoing pregnancy rates (OR 1.30, 95% confidence interval (CI) 0.95 to 1.76; I² = 16%, 9 RCTs, N = 1433, moderate certainty evidence). This suggests that in women with a 12% chance of live birth/ongoing pregnancy with placebo or no treatment, the live birth/ongoing pregnancy rate in women using DHEA will be between 12% and 20%. DHEA likely does not decrease miscarriage rates (OR 0.85, 95% CI 0.53 to 1.37; I² = 0%, 10 RCTs, N =1601, moderate certainty evidence). DHEA likely results in little to no difference in clinical pregnancy rates (OR 1.18, 95% CI 0.93 to 1.49; I² = 0%, 13 RCTs, N = 1886, moderate certainty evidence). This suggests that in women with a 17% chance of clinical pregnancy with placebo or no treatment, the clinical pregnancy rate in women using DHEA will be between 16% and 24%. We are very uncertain about the effect of DHEA on multiple pregnancy (OR 3.05, 95% CI 0.47 to 19.66; 7 RCTs, N = 463, very low certainty evidence). Pre-treatment with T versus placebo/no treatment: T likely improves live birth rates (OR 2.53, 95% CI 1.61 to 3.99; I² = 0%, 8 RCTs, N = 716, moderate certainty evidence). This suggests that in women with a 10% chance of live birth with placebo or no treatment, the live birth rate in women using T will be between 15% and 30%. T likely does not decrease miscarriage rates (OR 1.63, 95% CI 0.76 to 3.51; I² = 0%, 9 RCTs, N = 755, moderate certainty evidence). T likely increases clinical pregnancy rates (OR 2.17, 95% CI 1.54 to 3.06; I² = 0%, 13 RCTs, N = 1152, moderate certainty evidence). This suggests that in women with a 12% chance of clinical pregnancy with placebo or no treatment, the clinical pregnancy rate in women using T will be between 17% and 29%. We are very uncertain about the effect of T on multiple pregnancy (OR 2.56, 95% CI 0.59 to 11.20; 5 RCTs, N = 449, very low certainty evidence). We are uncertain about the effect of T versus estradiol or T versus estradiol + oral contraceptive pills. The certainty of the evidence was moderate to very low, the main limitations being lack of blinding in the included trials, inadequate reporting of study methods, and low event and sample sizes in the trials. Data on adverse events were sparse; any reported events were minor.

Authors' conclusions: Pre-treatment with T likely improves, and pre-treatment with DHEA likely results in little to no difference, in live birth and clinical pregnancy rates in women undergoing IVF who have been identified as poor responders. DHEA and T probably do not decrease miscarriage rates in women under IVF treatment. The effects of DHEA and T on multiple pregnancy are uncertain. Research is needed to identify the optimal duration of treatment with T. Future studies should include data collection on adverse events and multiple pregnancy.

PubMed Disclaimer

Conflict of interest statement

Sandeep Naik: none known

Sam Lepine: none known

Helen E Nagels: none known

Charalampos S Siristatidis: none known

Ben Kroon: none known

Simon McDowell: none known

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Live birth/ongoing pregnancy rate for DHEA intervention versus placebo/no treatment.
5
5
Live birth/ongoing pregnancy rate for T intervention versus placebo/no treatment.
6
6
Miscarriage rate for DHEA intervention versus placebo/no treatment.
7
7
Miscarriage rate for T intervention versus placebo/no treatment.
8
8
Clinical pregnancy rate for DHEA intervention versus placebo/no treatment.
9
9
Clinical pregnancy rate for T intervention versus placebo/no treatment.
10
10
Clinical pregnancy rate for DHEA intervention.
11
11
Clinical pregnancy rate for T intervention.
1.1
1.1. Analysis
Comparison 1: DHEA or testosterone versus placebo/no treatment, Outcome 1: Live birth/ongoing pregnancy rate ‐ DHEA
1.2
1.2. Analysis
Comparison 1: DHEA or testosterone versus placebo/no treatment, Outcome 2: Live birth/ongoing pregnancy rate ‐ T
1.3
1.3. Analysis
Comparison 1: DHEA or testosterone versus placebo/no treatment, Outcome 3: Miscarriage rate ‐ DHEA
1.4
1.4. Analysis
Comparison 1: DHEA or testosterone versus placebo/no treatment, Outcome 4: Miscarriage rate ‐ T
1.5
1.5. Analysis
Comparison 1: DHEA or testosterone versus placebo/no treatment, Outcome 5: Clinical pregnancy rate ‐ DHEA
1.6
1.6. Analysis
Comparison 1: DHEA or testosterone versus placebo/no treatment, Outcome 6: Clinical pregnancy rate ‐ T
1.7
1.7. Analysis
Comparison 1: DHEA or testosterone versus placebo/no treatment, Outcome 7: Multiple pregnancy
1.8
1.8. Analysis
Comparison 1: DHEA or testosterone versus placebo/no treatment, Outcome 8: Adverse effects to the woman
1.9
1.9. Analysis
Comparison 1: DHEA or testosterone versus placebo/no treatment, Outcome 9: Pregnancy complications
1.10
1.10. Analysis
Comparison 1: DHEA or testosterone versus placebo/no treatment, Outcome 10: Sensitivity analyses
2.1
2.1. Analysis
Comparison 2: Testosterone versus other active interventions, Outcome 1: Live birth/ongoing pregnancy
2.2
2.2. Analysis
Comparison 2: Testosterone versus other active interventions, Outcome 2: Clinical pregnancy rate
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Aflatoonian 2022 {published data only}
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Artini 2012 {published data only}
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Kim 2011 {published data only}
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Kotb 2016 {published data only}
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Massin 2006 {published data only}
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Moawad 2012 {published data only}
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Mostajeran 2018 {published data only}
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Muhammed 2023 {published data only}
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Narkwichean 2017 {published data only}
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Saharkhiz 2017 {published data only}
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Sharma 2023 {published data only}
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Singh 2021 {published data only}
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Subira 2021 {published data only}
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Tartagni 2015 {published data only}
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Wang 2021 {published data only}
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Wiser 2010 {published data only}
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Yeung 2014 {published data only}
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References to studies excluded from this review

Agarwal 2017 {published data only}
    1. Agarwal R, Shruthi R, Radhakrishnan G, Singh A. Evaluation of dehydroepiandrosterone supplementation on diminished ovarian reserve: a randomized, double-blinded, placebo-controlled study. Journal of Obstetrics and Gynecology of India 2017;67(2):137-42. - PMC - PubMed
Al‐Turki 2018 {published data only}
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Balasch 2006 {published data only}
    1. Balasch J, Fábregues F, Peñarrubia J, Carmona F, Casamitjana R, Creus M, et al. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Human Reproduction 2006;21(7):1884-93. - PubMed
Balasubramanyam 2017 {published data only}
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Barad 2006 {published data only}
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Barad 2007 {published data only}
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Barad 2008b {unpublished data only}
    1. Barad D. A trial of dehydroepiandrosterone (DHEA) treatment for in vitro fertilization (IVF). clinicaltrials.gov/ct2/show/NCT00419913.
Bercaire 2018 {published data only}
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Bosdou 2016a {published data only}
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Bradley 2020 {published data only}
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Casson 2000 {published data only}
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Çelik 2017 {published data only}
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Chaudhary 2019 {published data only}
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Christoforaki 2020 {published data only}
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de los Santos 2013 {published data only}
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Di Filippo 2016 {published data only}
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Doan 2017 {published data only}
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Dosouto 2016 {published data only}
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Duport 2017 {published data only}
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Fusi 2013 {published data only}
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Fusi 2013a {published data only}
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Gleicher 2013 {published data only}
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Gleicher 2016 {published data only}
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Hong 2016 {published data only}
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Hu 2017 {published data only}
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Hui 2017 {published data only}
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Hyman 2013 {published data only}
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Ji 2016 {published data only}
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Kachhawa 2014 {published data only}
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Katsika 2022 {published data only}
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Li 2015 {published data only}
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Li 2016 {published data only}
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Lin 2015 {published data only}
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Lin 2017 {published data only}
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Lin 2017a {published data only}
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Liu 2018 {published data only}
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References to studies awaiting assessment

Divita 2003 {published data only}
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References to ongoing studies

CTRI/2020/06/025918 {unpublished data only}
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IRCT20160523028008N14 {unpublished data only}
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References to other published versions of this review

Nagels 2012
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