Preparing and Timing of the Endometrium in Modified Natural Cycle Frozen-thawed Embryo Transfers

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The increasing use of FET emphasizes the importance of preparing and timing the endometrium in FET cycles, however there is no consensus on luteal phase progesterone supplementation in mNC-FET and the optimal day of blastocyst warming and transfer. The aim of this multicenter RCT is to assess the effect of progesterone supplementation in hCG-triggered mNC-FET and the effect of embryo thawing and transfer at hCG+6 or hCG+7 days, respectively. In total 604 patients will be included with n=151 in each of the four study arms. The primary outcome is live birth rate per transfer (LBR) and the goal is to show a 10% increase in LBR after progesterone supplementation and to assess whether blastocyst warming+transfer 6 days after hCG trigger is superior to 7 days after hCG trigger in mNC-FET.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anja Bisgaard Pinborg
• Collaborators: Aalborg University Hospital; Copenhagen University Hospital at Herlev; Copenhagen University Hospital, Hvidovre; Hillerod Hospital, Denmark; I. Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital; II. Kvindeafdelingen, Horsens og Institut for Klinisk Medicin, Århus Universitet; III. Fertility Clinic, Herlev Hospital, Copenhagen University Hospital; IV. Fertilitetsenheden og Center for Præimplantationsdiagnostik, Ålborg Universitetshospital; Regionshospitalet Horsens; Regionshospitalet Viborg, Skive; Zealand University Hospital
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Female age 18-41 years, regular menstrual cycle (23-35 days), vitrified blastocysts derived from 1.-3. IVF/ICSI cycle in a public hospital and undergoing single blastocyst transfer.

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.