Authorised Therapeutic use (Phase IV) unexplained subfertillity, infertillity

Does progesterone luteal‑phase support increase live birth rates in couples with unexplained infertility assigned to expectant management?

EU CTIS ID: 2026-525747-33-00

What this study is testing

To evaluate whether progesterone luteal phase support in women with unexplained infertillity during expectant management increases live birth rates, in comparison to no treatment (placebo arm).

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Female BMI <45 kg/m2
  • Female age ≥18 years old
  • assignment to expectant management during at least six months, in accordance with Dutch NVOG Guidelines
  • a Hunault prognostic score greater than or equal to 30%
  • primary or secondary infertility for at least a period of 1 year
  • regular menstrual cycle ranging between 21-35 days

You likely can't join if

  • 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
  • Formal diagnosis of endometriosis
See the full eligibility criteria
Who can join
  • Female BMI <45 kg/m2
  • Female age ≥18 years old
  • assignment to expectant management during at least six months, in accordance with Dutch NVOG Guidelines
  • a Hunault prognostic score greater than or equal to 30%
  • primary or secondary infertility for at least a period of 1 year
  • regular menstrual cycle ranging between 21-35 days
  • total motile sperm count greater than or equal to 10 million/ml
  • no risk of tubal pathology (or in case of increased risk, tubal pathology excluded by tubal patency testing)
What rules you out
  • 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
  • Formal diagnosis of endometriosis

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.