Overview
Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone
Status:
Recruiting
Recruiting
Trial end date:
2024-03-01
2024-03-01
Target enrollment:
0
0
Participant gender:
Female
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Hospital, GhentTreatments:
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