Preparing and timing of the endometrium in modified natural cycle frozen-thawed embryo transfer (mNC-FET) - A randomized controlled multicenter trial

Phase 1

• Conditions: Infertility; MedDRA version: 21.0Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-002207-34-DK
• Lead Sponsor: Anja Bisgaard Pinborg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-15
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 670

Inclusion Criteria

Inclusion criteria
? Female age 18-41 years
? Regular menstrual cycle (23-35 days)
? Vitrified blastocysts derived from 1.-3. IVF/ICSI cycle resulting in an embryo transfer in a public hospital
? Undergoing single blastocyst transfer.

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 670
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous participation in the study, uterine malformations, intrauterine polyps or submucosal myomas, breast feeding, oocyte donation, preimplantation genetic testing, blastocyst conceived with sperm from testicular sperm aspiration, HIV (woman), hepatitis B and C (woman), known luteal phase insufficiency or if patients are not fulfilling the inclusion criteria. Further exclusion criteria are the following contraindications to progesterone; allergy to the study medication, undiagnosed vaginal bleeding, current missed abortion or ectopic pregnancy, hepatic insufficiency or severe hepatic disease, genital or breast cancer, arterial or venous thromboembolism, thrombophlebitis or porphyria. For patients participating in the sub-study, thyroid disease is an exclusion criterion.

Study & Design

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