Endometrial Preparation in Frozen Embryo Transfer Cycles
NCT ID: NCT06181305
Last Updated: 2024-02-26
Study Results
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Basic Information
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RECRUITING
PHASE4
210 participants
INTERVENTIONAL
2024-02-24
2024-12-25
Brief Summary
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Detailed Description
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A recent study has found that incorporation of the aromatase inhibitor (letrozole) to HRT cycles was associated with better FET outcomes in comparison to HRT cycles alone. Ongoing pregnancy rate (OPR) was higher in HRT plus letrozole group than HRT only group.
Letrozole is a third-generation aromatase inhibitor that leads to mono-ovulatory cycles with short half-life . Miller and his colleagues found that letrozole increased Integrin expression and improved pregnancy and implantation rates among women with endometrial receptivity defects . Another study found that ovarian stimulation with letrozole was associated with increase in the expression of uterine receptivity markers including integrin, leukemia inhibitory factor, and L-selectin.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
estradiol valerate and letrozole
hormone replacement therapy by estradiol valerate plus letrozole incorporation .
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.
letrozole 2,5 mg tablet
mild ovarian stimulation
Interventions
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estradiol valerate and letrozole
hormone replacement therapy by estradiol valerate plus letrozole incorporation .
letrozole 2,5 mg tablet
mild ovarian stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Women who will not reach the optimal endometrium.
* Participants that don't have at least one good-quality blastocyst for transfer after warming.
* PGT embryos will be excluded.
18 Years
37 Years
FEMALE
No
Sponsors
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Rahem Fertility Center
OTHER
Responsible Party
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Eman Elgindy
doctor
Principal Investigators
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Eman El-gindy, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Rahem Fertility Center
Locations
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Rahem fertility center
Zagazig, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Elgindy EA, Abdelghany AA, Sibai AbdAlsalam H, Mostafa MI. The novel incorporation of aromatase inhibitor in hormonal replacement therapy cycles: a randomized controlled trial. Reprod Biomed Online. 2022 Apr;44(4):641-649. doi: 10.1016/j.rbmo.2021.10.025. Epub 2021 Dec 20.
Ezoe K, Fukuda J, Takeshima K, Shinohara K, Kato K. Letrozole-induced endometrial preparation improved the pregnancy outcomes after frozen blastocyst transfer compared to the natural cycle: a retrospective cohort study. BMC Pregnancy Childbirth. 2022 Nov 7;22(1):824. doi: 10.1186/s12884-022-05174-0.
An BGL, Chapman M, Tilia L, Venetis C. Is there an optimal window of time for transferring single frozen-thawed euploid blastocysts? A cohort study of 1170 embryo transfers. Hum Reprod. 2022 Nov 24;37(12):2797-2807. doi: 10.1093/humrep/deac227.
Mumusoglu S, Polat M, Ozbek IY, Bozdag G, Papanikolaou EG, Esteves SC, Humaidan P, Yarali H. Preparation of the Endometrium for Frozen Embryo Transfer: A Systematic Review. Front Endocrinol (Lausanne). 2021 Jul 9;12:688237. doi: 10.3389/fendo.2021.688237. eCollection 2021.
Zhang J, Liu H, Wang Y, Mao X, Chen Q, Fan Y, Xiao Y, Kuang Y. Letrozole use during frozen embryo transfer cycles in women with polycystic ovary syndrome. Fertil Steril. 2019 Aug;112(2):371-377. doi: 10.1016/j.fertnstert.2019.04.014. Epub 2019 May 21.
Godiwala P, Makhijani R, Bartolucci A, Grow D, Nulsen J, Benadiva C, Grady J, Engmann L. Pregnancy outcomes after frozen-thawed embryo transfer using letrozole ovulation induction, natural, or programmed cycles. Fertil Steril. 2022 Oct;118(4):690-698. doi: 10.1016/j.fertnstert.2022.06.013. Epub 2022 Jul 19.
Lawrenz B, Melado L, Fatemi HM. Frozen embryo transfers in a natural cycle: how to do it right. Curr Opin Obstet Gynecol. 2023 Jun 1;35(3):224-229. doi: 10.1097/GCO.0000000000000862. Epub 2023 Mar 14.
Other Identifiers
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endometrial preparation
Identifier Type: -
Identifier Source: org_study_id
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