The purpose of this study is to evaluate whether progesterone in women with unexplained infertility can increases live birth rate.
The main research question is:
Does luteal phase support with progesterone increase the live birth rate among couples with unexplained infertility?
The study compares progesterone with placebo to determine the effectiveness of progesterone in unexplained infertility.
Study participants will:
* Perform home ovulation tests and maintain a digital diary to record menstrual cycles and study medication use.10 * Take progesterone or placebo twice daily during the luteal phase of each menstrual cycle for up to six months.11 * Continue usual medical care. No additional hospital visits or invasive procedures are required as part of the study.
Primary or secondary infertility for at least a period of 1 year Participants whose previous pregnancy was achieved through MOH-IUI or IVF are eligible to join the study, provided they are willing to continue expectant management for at least six months before considering any further fertility interventions
Diagnosis of UI after infertility work-up, i.e.
regular menstrual cycle ranging between 21-35 days,
total motile sperm count ≥ 10 million/ml,
Uncorrected uterine factors, such as endometrial polyps or submucosal fibroids,
Insufficient knowledge or understanding of the Dutch or English language and not willing or able to receive study information via a certified translator
Not able or willing to provide (written) informed consent
Contraindications for vaginal progesterone, in particular: females with allergy to peanuts or soya.
Simone Broer
Lead sponsor
UMC Utrecht
Sponsor institution
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator