Progesterone Luteal Support in Unexplained Infertility Management

ConditionsInfertility Female Infertility Subfertility Infertility Primary Infertility Secondary Subfertility, Female

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age18-43

SponsorSimone Broer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Utrogestan® 200 mg Soft Capsule
Drug
progesteron versus placebo
Placebo soft capsule 200 mg
Drug
placebo

Treatment groups

640 Participants

are divided into 2 treatment groups

Group A: 1. The Progesterone ArmExperimental treatment 1 intervention

Group B: 2. The Placebo (Control) ArmPlacebo comparator 1 intervention