Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as < 10 mcg/l) on the day of blastocyst transfer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Informed consent form (ICF) dated and signed

• Age ≥ 18 and < 40 years old

• Body Mass Index (BMI) ≥ 18.5 kg/m2 and < 35 kg/m2

• Less than 4 previous Assisted Reproductive Technologies (ART) cycles

• Current pregnancy wish

• Patients undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle (IVF or ICSI)

Exclusion Criteria:

• Simultaneous participation in another clinical study

• Previous participation in this study

• Known reasons for impaired implantation (specifically: presence of a hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, ≥ grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis)

• Repeated miscarriages (> 2 previous biochemical pregnancies or > 2 spontaneous miscarriages)

• Untreated and uncontrolled thyroid dysfunction

• Tumors of the ovary, breast, uterus, pituitary or hypothalamus

• Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause

• Ovarian cysts or enlarged ovaries

• Fibroid tumors of the uterus incompatible with pregnancy

• Malformations of the reproductive organs incompatible with pregnancy

• Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin)

• Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia

• Active smoking

• Ongoing pregnancy

• Use of carbamazepine, rifampicin or phenytoin

• Those unable to comprehend the investigational nature of the proposed study