The exogenous progesterone free luteal phase after GnRHa trigger – a randomized controlled pilot study in high-responder IVF patients

Phase 1

• Conditions: Infertility; MedDRA version: 17.0Level: LLTClassification code 10016398Term: Female infertilitySystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-000448-13-DK
• Lead Sponsor: The Fertility Clinic, Skive Regional Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-31
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

The inclusion criteria will be age between 20 and 40 years either normal menstrual cycles 25-34 days or oligomenorrhea/amenorrhea or polycystic syndrome (defined according to the Rotterdam criteria 2004). BMI >18 and <35 kg/m2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with <14 and >25 follicles on day of trigger
Previous hyper response with OHSS development after GnRH trigger, previous low response (less than 3 oocytes on a high dose of FSH stimulation) and endocrine disorders

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified