Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone (PROTECTA)

Ghent University Hospital (UZ)

Status and phase: Enrolling; Phase 3

Conditions: Luteal Phase Defect; IVF; Embryo Loss

Treatments: Drug: Progesteron TID

Study type: Interventional

Funder types: Other

Identifiers

NCT04806919

2020-004112-10

Details and patient eligibility

About

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.

Enrollment: 242 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

Control group: Amelgen ® 400 mg BID

No Intervention group

Description:

Continue daily dose progesteron

Intervention group: Amelgen ® 400 mg TID

Experimental group

Description:

Increase daily progesteron dose

Treatment:

Drug: Progesteron TID