Hormonal Replacement Therapy Plus Letrozole Incorporation Versus Letrozole Mild Ovarian Stimulation in Endometrial Preparation for Frozen Embryo Transfer: A Randomised Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
In order to get optimal pregnancy rates after frozen embryo transfer (FET), the embryo stage and endometrium should be synchronized. Endometrial preparation is done by either natural, artificial (Hormonal replacement therapy HRT) , modified natural methods or mild ovarian stimulation. HRT cycle has a better schedualization however, there are some reports about higher rates of miscarriage, pregnancy induced hypertension (PIH) and preeclampsia (PET) in HRT cycles. A recent study has found that incorporation of the aromatase inhibitor (letrozole) to HRT cycles was associated with better FET outcomes in comparison to hormonal replacement therapy cycles alone. Meanwhile, mild ovarian stimulation protocol can be done either by oral drugs like letrozole or by letrozole plus gonadotropins . So this study aims to compare the reproductive outcomes in two endometrial preparation protocols for frozen embryo transfer cycles; letrozole mild ovarian stimulation versus HRT plus letrozole incorporation.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 37
Healthy Volunteers: f
View:
• Women aged between 18 and 37 years with either regular cycles or oligomenorrhoea or amenorrhoea.
• Women undergoing FET cycles.
• Participants should have at least one good-quality blastocyst available for vitrification and also for transfer after warming.
• Participants having optimal endometrium before starting luteal phase support
Locations
Other Locations
Egypt
Rahem fertility center
RECRUITING
Zagazig
Contact Information
Primary
Noha Moustafa El-hibishy, MSc
nohaesmaeelobgyn@yahoo.com
00201067411131
Backup
Eman El-gindy, MD,PhD
eman_elgindy2013@hotmail.com
00201227491143
Time Frame
Start Date:2024-02-24
Estimated Completion Date:2024-12-25
Participants
Target number of participants:210
Treatments
Experimental: Group A (HRT plus letrozole incorporation)
Exogenous oestradiol in the form of 2 mg oral oestradiol valerate , three times daily will be started on the 2nd or 3rd day of the cycle. Tri-laminar endometrium of ≥ 9 mm will be the targeted cut-off. If the endometrium does not yet reach the target, oestradiol supplementation will be continued with serial US assessment until the targeted cut-off will be reached. Upon reaching the target endometrium, oral letrozole tablets 2.5 mg will be started twice daily for 5 days only with continuation of 6 mg daily oestradiol supplementation. Then, daily intramuscular progesterone in oil (100 mg intramuscular progesterone) will be started once per day with continuation of 6 mg oestradiol~interventions:~Drug:estradiol valertae~Drug :letrozole 2.5 mg tablet
Active_comparator: Group B (Letrozole mild ovarian stimulation)
Oral letrozole 2.5-5 mg daily on cycle day(3-7) will be added . TVS will be performed from cycle day 8-10 to make sure that a dominant follicle has been recruited with the endometrium thickness ≥ 7 mm . Upon reaching the dominant follicle (18-20mm) , endometrial thickness will be measured on the day of ovulation trigger and blood sample will be withdrawn from each patient for assessment of E2 , P4 and LH levels. Patients with low LH level , high E2 level , low P4 level (\<1 ng/ml) will continue in the RCT; 10,000unit HCG will be injected as ovulation trigger~intervention :~Drug :letrozole 2.5mg tablet~procedure: on the day of ovulation trigger blood sample will be withdrawn from each patient for assessment of E2 , P4 and LH levels.