Abstract
Objective
To assess the association of baseline anti-Müllerian hormone (AMH) levels with ovulation, time to ovulation and fertility outcomes in women with polycystic ovary syndrome (PCOS) receiving clomiphene citrate (CC) and compare this with placebo.
Design
Secondary analysis of the PCOSAct trial (NCT01573858).
Setting
27 trial centres in mainland China.
Population or sample
1000 infertile women with PCOS receiving either CC or placebo.
Methods
Baseline serum AMH was measured and analysed as a continuous and as a categorical variable. Interaction between AMH and CC was tested. Predictive values of AMH for ovulation, time to ovulation and fertility outcomes were assessed.
Main outcome measures
Ovulation and time to ovulation.
Results
900 baseline AMH data were available for analysis. There were no significant interactions with ovulation or conception for AMH and CC treatment (P = 0.782 and 0.419, respectively). Women in the upper quartile of AMH >15.88 ng/ml had significant lower ovulation (odds ratio [OR] 0.34, 95% CI 0.20–0.58) and conception rates (OR 0.65, 95% CI 0.42–1.00) compared with women in the lower quartile. Associations of AMH with clinical pregnancy (OR 0.98, 95% CI 0.95–1.01) and live birth (OR 0.98, 95% CI 0.96–1.01) were not significant. Ovulation rate increased until baseline AMH levels ≥7.0 ng/ml in women treated with CC but decreased when AMH increased in women with placebo. When AMH <7.0 ng/ml, an AMH threshold at 4.11 ng/ml predicted ovulation in women receiving CC (area under the curve [AUC] 0.64, 95% CI 0.42–0.86), with a sensitivity of 64% and a specificity of 62%, whereas prediction was poor for AMH ≥7.0 ng/ml (AUC 0.38, 95% CI 0.28–0.47). Median time to ovulation was 35 days in the lower quartile for women with placebo but this was significantly prolonged up to 98 days in the upper quartile. CC significantly shortened the time to ovulation up to 56 days.
Conclusions
Among women with PCOS, high baseline AMH levels were associated with a 20.1% lower chance of ovulation with a 63-day longer time to ovulation. AMH can predict ovulation only when the baseline AMH level was <7.0 ng/ml in women with PCOS undergoing ovulation induction with CC.
Tweetable abstract
Ovulation rate increased until baseline AMH levels ≥7.0 ng/ml in women treated with CC; a successful ovulation and time to ovulation was highly associated with baseline AMH level in these women.
Original language | English |
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Pages (from-to) | 1477-1486 |
Number of pages | 10 |
Journal | BJOG-An International Journal of Obstetrics and Gynaecology |
Volume | 128 |
Issue number | 9 |
Early online date | 30 May 2021 |
DOIs | |
Publication status | Published - 1 Aug 2021 |
Bibliographical note
FundingNational Public Welfare Projects for Chinese Medicine (201507001). Health and Medical Research Fund from Food and Health Bureau, The Government of the Hong Kong Special Administrative Region (06171026).
Acknowledgements
The Steering Committee (SC) members included Tai-Xiang Wu, Elisabet Stener-Victorin and Heping Zhang, and Richard S Legro (Chair). The Data and Safety Monitoring Board (DSMB) members included Esther Eisenberg, Wei-Liang Weng, Su-Lun Sun, Wei Zou and Zi-Dan Chen, and Robert Rebar (Chair). Meizhuo Zhang, in Yale, contributed to the randomisation scheme and training of our study personnel. Other personnel with administrative resource supports included Song-Jiang Liu, Gui-Yuan Wang, Yan-Qiu Du, Yang Xia, Shu-Lai Li, Ke-Qiu Zhang, and Jian-Hua Shen. Yan Li, Wen-Juan Shen, Wei Li and Jing Cong were involved in protocol preparation and blood sample management in the Harbin office and core laboratory.
Keywords
- Anti-Müllerian hormone
- Ovulation
- polycystic ovary syndrome
- time to ovulation