Overview

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