Abstract
Research question: Can women be identified, on the basis of baseline patient characteristics, as having better chances of an ongoing pregnancy with FSH instead of clomiphene citrate as stimulation agent in intrauterine insemination for unexplained subfertility? Design: A secondary analysis of a multicentre randomized controlled superiority trial; the SUPER study. Between July 2013 and March 2016, couples with unexplained subfertility undergoing intrauterine inemination (IUI)were allocated to an FSH or clomiphene citrate group. Female age, body mass index, duration of subfertility, primary versus secondary subfertility, antral follicle count and total motile count were assessed. For each of these factors, a logistic regression model was developed to assess if different estimated effects of FSH versus clomiphene citrate on ongoing pregnancy occurred within strata of each factor. Results: A total of 684 couples received 2259 IUI cycles; 338 couples were allocated to FSH, of which 84 conceived leading to ongoing pregnancy and 346 couples were allocated to clomiphene citrate, of which 71 conceived leading to ongoing pregnancy. None of the treatment selection markers was associated with better ongoing pregnancy chances after IUI with FSH compared with clomiphene citrate. Conclusion: In couples with unexplained subfertility undergoing IUI, no baseline treatment selection markers could be identified to determine whether ovaries should be stimulated with FSH or clomiphene citrate.
Original language | English |
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Pages (from-to) | 938-942 |
Number of pages | 5 |
Journal | Reproductive Biomedicine Online |
Volume | 38 |
Issue number | 6 |
Early online date | 22 May 2019 |
DOIs | |
Publication status | Published - Jun 2019 |
Bibliographical note
Prof Dr. BWJ Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for Merck, ObsEva and Guerbet. The initial randomized controlled trial received funding from the Dutch Organization for Health Research and Development (ZonMw) (Health Care Efficiency Research; project number 80-83600-98-10192). The Eudract number for this trial was 2013-001034-18. Trial registration: NTR 4057.Acknowledgements: We thank all couples that participated in the SUPER study, the hospitals and their staff, the research nurses and the staff of the Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynaecology for logistic support and the staff of the Clinical Research Unit of the Academic Medical Centre, Amsterdam for their help with the randomization program and the online database. ND is responsible for the overall logistical aspects of the study and drafted the paper. MM, FvdV and MW designed the study. RvE is responsible for the statistical analysis. All authors contributed and approved the final version of the paper.
Data Availability Statement
No data availability statementKeywords
- Clomiphene citrate
- Follicle stimulating hormone
- Intrauterine insemination
- IUI
- Treatment selection markers