Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients

NCT06239376 · ctgov recruiting

Enrollment: 222
Start: 2024-02-19
Completion: 2027-05-30
Last updated: 2026-07-01
Has results: False
Countries: Vietnam

Conditions

AdenomyosisIVFFrozen Embryo Transfer

Tagged with

adenomyosis

Interventions

GnRHa+AI - AC PROCEDURE
Pre-treatment includes two doses of 3.75 mg GnRH agonist (Diphereline®, Ipsen, France) on days 2-4 of the menstrual cycle and 28 days later, along with daily 2.5 mg Letrozole (Femara®, Novartis, Switzerland) starting from the first agonist injection. Endometrial preparation in an artificial cycle begins 28 days after the second agonist injection. Patients take 6 mg/day of oral estradiol valerate (Valiera; Abbott) at least 9 days before progesterone. Endometrial thickness is monitored starting on the 10th day. When it reaches ≥7 mm, 400 mg twice times a day of vaginal progesterone (Cyclogest®, Actavis, UK) is initiated. Embryo transfer aligns with progesterone initiation, taking the embryo's stage into account. Luteal phase support comprises oral estradiol valerate 4 mg/day and vaginal progesterone 400 mg twice times a day until the 7th week of gestational age (GA), followed by progesterone alone at 400 mg twice times a day up to the 12th week of GA.
Artificial cycle PROCEDURE
The endometrium will be prepared using oral estradiol valerate (Valiera; Abbott) 6 mg/day starting from the 2nd to the 4th day of the menstrual cycle. The endometrial thickness will be monitored from day 10th onwards, and vaginal progesterone (Cyclogest®; Actavis) 400 mg twice times a day will be initiated when endometrial thickness reaches ≥7 mm. Estradiol exposure must last for at least 9 days before progesterone administration. Embryo transfer will be scheduled by the time of the initiation of progesterone and embryo stages. Luteal phase support comprises estradiol 4 mg/day and vaginal progesterone 400 mg twice times a day until the 7th week of gestational age (GA), followed by progesterone alone at 400 mg twice times a day up to the 12th week of GA.

Eligibility criteria

Inclusion Criteria: * Confirm diagnosis with adenomyosis by using transvaginal ultrasonography (MUSA consensus) and/or pelvic magnetic resonance imaging. * Age between 18 - 42 * Undergo less or equal to three previous IVF cycles * Indicate for frozen embryo transfer * Agree to have not more than two day-3 embryo or one blastocyst (day-5 and day-6) transferred * Not participating in any other study Exclusion Criteria: * Embryos from IVM cycle * Having uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal leiomyoma, or leiomyoma with endometrial cavity distortion) * Having contraindications for exogenous hormones administration: breast cancer, risks of venous thromboembolism * Embryos from the oocyte donation cycle. * Patients with a history of GnRH injection within three months, measured from the last GnRHa injection to the study screening date.

License: public-domain-us · commercial use OK · attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine