Progesterone Luteal Support in Unexplained Infertility Management

Sponsor
Simone Broer
Study ID
NCT07738068
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 43 Years
Healthy Volunteers
Not accepted

Interventions

  • Utrogestan® 200 mg Soft Capsule — DRUG
    progesteron versus placebo
  • Placebo soft capsule 200 mg — DRUG
    placebo

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Aug 1, 2030
Completion
Jan 1, 2031

Study Design

Enrollment
640 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1. The Progesterone Arm
    Female participants apply vaginal micronized progesterone (Utrogestan) during the luteal phase of their cycle, at a dosage of 300 mg twice daily
  • Placebo Comparator: 2. The Placebo (Control) Arm
    Female participants apply a vaginal capsule (placebo) during the luteal phase of their cycle, at a dosage of 300 mg twice daily

Primary Outcome Measure

Pregnancy occurring within 6 months after randomisation, leading to a live birth. [ Time Frame: within 6 months after randomisation ]

Central Contacts

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