Clinical trial NCT04806919: Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone
Official title: Randomized Controlled Trial Comparing Micronized Progesterone (Amelgen ®) 400 mg BID Versus 400 mg TID for Luteal Support in Artificial Vitrified/Warmed Single Blastocyst Transfer Cycles With Low Progesterone on Day of Embryo Transfer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: IVF
Embryo Loss
Luteal Phase Defect
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Informed consent form (ICF) dated and signed
* Age ≥ 18 and \< 43 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 miscarriages)
* Untreated and uncontrolled thyroid dysfunction
* Tumors of the ovary, breast, uterus, pituitary or hypothalamus
* Abnormal 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

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 7 gestational weeks (+ or - 1 week)
Secondary outcomes:
measure: Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate
timeFrame: 7 gestational weeks (+ or - 1 week)
Other outcomes:
measure: Questionnaire on patient comfort and side effects
timeFrame: On the day of embryo transfer (day 5)
measure: Questionnaire on patient comfort and side effects
timeFrame: On the day of the initial pregnancy test (day 16 (± 2 days))
Locations:
city: Ghent
country: Belgium
facility: UZ Ghent
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
References: