Eight weeks of pre-treatment with hCG before in vitro fertilization in women with low ovarian reserve.

Phase 1

• Conditions: Female Infertility; MedDRA version: 20.1Level: LLTClassification code 10016399Term: Female infertility (primary)System Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-002453-26-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-09
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Age 18-40 (both inclusive); regular menstrual cycle between 23 and 35 days; AMH < 6.29 pmol/L, willingness to undergo two consecutive identical controlled ovarian stimulations with a freeze-all strategy employed after the first stimulation.
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria are uterine malformations, submucosal myomas, intrauterine polyps, hydrosalpinx, endometriosis stage III-IV, severe comorbidity (i.e. IDDM, NIDDM, gastrointestinal, cardiovascular, pulmonary, liver or kidney diseases, HIV or Hepatitis B/C, dysregulation of thyroid disease), need for testicular sperm aspiration, preimplantation genetic testing, not Danish or English speaking, previous inclusion, or allergy to Ovitrelle or other standard IVF medication.

Study & Design

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