Adenomyosis and Infertility-Review of Medical and Surgical Approaches.
Maria Szubert, Edward Koziróg, Olga Olszak...
https://pubmed.ncbi.nlm.nih.gov/33573117/Actively Recruiting
Led by Mỹ Đức Hospital · Updated on 2026-07-01
222
Participants Needed
1
Research Sites
6 weeks
Total Duration
Researchers are investigating the effectiveness of two different methods for preparing the uterus lining before frozen embryo transfer in women with adenomyosis undergoing IVF or ICSI. Adenomyosis is a benign condition where tissue normally lining the uterus grows into its muscle, causing infertility and other complications. This randomized clinical trial seeks to determine if combining a GnRH agonist and letrozole with hormone therapy leads to a higher live birth rate compared to hormone therapy alone. Participants are randomly assigned to one of two groups. One group receives pre-treatment with two doses of a GnRH agonist and daily letrozole before starting an artificial cycle with oral estradiol valerate and vaginal progesterone. The other group receives only the artificial cycle hormone treatment without pre-treatment. Embryos are thawed and transferred based on progesterone timing, and hormone support continues through early pregnancy. The trial also evaluates side effects of the pre-treatment and analyzes future babies health and cost-effectiveness. During the study, participants undergo screenings including ultrasound and hormone level tests. Endometrial thickness is monitored, and embryo transfer is performed under ultrasound guidance. Researchers measure outcomes such as live birth rate, pregnancy rates, side effects, pregnancy complications, and newborn health. The study follows participants through pregnancy up to birth and records various fetal and maternal outcomes. Participation lasts from screening through treatment and follow-up until delivery.
CONDITIONS
Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients
T
Tien K Le, MD
V
Vu NA Ho, MD
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Mỹ Đức Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening occurs on days 2 to 4 of the menstrual cycle in frozen embryo transfer cycles.
Duration - Approximately 2 months for pre-treatment plus hormone preparation duration
Participants assigned to the GnRHa+AI - AC group receive two doses of GnRH agonist and daily letrozole over two months before starting hormone therapy. Participants in the artificial cycle group start oral estradiol valerate and vaginal progesterone to prepare the uterus lining without pre-treatment.
Regular monitoring of endometrial thickness and hormone levels during preparation.
Duration - Up to 12 weeks of gestation
Embryos are thawed and transferred under ultrasound guidance based on progesterone timing. Hormonal support continues with estradiol and progesterone through the 7th week of gestation, then progesterone alone until the 12th week.
Follow-up visits for pregnancy monitoring at specified intervals.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor