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Progesterone Luteal Support in Unexplained Infertility Management

NCT07738068 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-07-30

No results posted yet for this study

Summary

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.

Conditions

  • Infertility
  • Female Infertility
  • Subfertility
  • Infertility Primary
  • Infertility Secondary
  • Subfertility, Female

Interventions

DRUG

Utrogestan® 200 mg Soft Capsule

progesteron versus placebo

DRUG

Placebo soft capsule 200 mg

placebo

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Simone Broer

    lead OTHER

Principal Investigators

  • Simone L. Broer, Gynaecologist, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2030-08-01
Completion
2031-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07738068 on ClinicalTrials.gov