Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

NCT04806919 — Phase 3, Completed, 87 participants, University Hospital, Ghent

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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

Registry	NCT04806919, acronym PROTECTA
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	87 (Actual)
Sponsor	University Hospital, Ghent (Other)
Conditions	IVF, Embryo Loss, Luteal Phase Defect
Interventions	Progesteron TID (Drug)
Dates	start 2021-04-02, primary completion 2025-02-28, completion 2025-03-31, first posted 2021-03-19, last updated 2026-03-23
Locations	2 sites in Belgium

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Control group: Amelgen ® 400 mg BID	No intervention		Continue daily dose progesteron
Intervention group: Amelgen ® 400 mg TID	Experimental	Drug: Progesteron TID	Increase daily progesteron dose

Progesteron TID (Drug): increasing the dose

+Outcome measures

Primary outcomes

Ongoing pregnancy rate [7 gestational weeks (+ or - 1 week)]: visualization of an embryo with a heart beat

Secondary outcomes

Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate [7 gestational weeks (+ or - 1 week)]

Other outcomes

Questionnaire on patient comfort and side effects [On the day of embryo transfer (day 5)]
Questionnaire on patient comfort and side effects [On the day of the initial pregnancy test (day 16 (± 2 days))]

+Eligibility

Sex: Female, ages: 18 Years to 43 Years

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

+Locations (2)

Facility	City	Country	Status
UZ Ghent	Ghent	Belgium
AZ Delta	Roeselare	Belgium