Administration of Human Chorionic Gonadotrophin Before Secretory Transformation of Frozen-thawed Embryo Transfer Cycles

Study Overview
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Brief Summary
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Successful embryo implantation is complicated process that requires synchrony between good-quality embryos and receptive endometrium. Human chorionic gonadotropin (hCG), is one of the initial embryonic signals and the major embryoendometrial relationship regulator. This study will be conducted to to investigate the role of parenteral hCG used for the transfer of cryopreserved- thawed embryos with HRT cycles in the outcome of artificially prepared frozen embryo transfer (FET) cycles.

Official Title
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Administration of Human Chorionic Gonadotrophin Before Secretory Transformation of Frozen-thawed Embryo Transfer Cycles

Conditions
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FET, hCG, Frozen-thawed Embryo Transfe, Human Chorionic Gonadotrophin

Intervention / Treatment
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* Drug: Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age ≤ 38 years. Normal 3D transvaginal ultrasound. At least two good quality embryos cryopreserved by vitrification. No GnRH agonists administration before FET cycle. Exclusion Criteria Endometriosis. Uterine anomalies. Evidence of hydrosalpinx by hystrosalpingography or ultrasound. Evidence of immune disease, hematological or hormonal disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCG group<br>n Group 1 (hCG): participants will receive endometrial preparation with estrogen and an intramuscular hCG injection will before progesterone supplementation | Drug: Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU<br>* From the 12th to 13th day of the cycle when endometrium reached the optimal thickness ≥8 mm, group 1 (hCG) will receive 10.000 IU hCG intramuscular injection in the morning then vaginal suppository progesterone 400 mg twice a day will be started in the afternoon<br>|
| No Intervention: control group<br>Group 2 (control): participants will receive the conventional endometrial preparation with estrogen followed by progesterone supplementation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth delivery rate (LBR) | Number of live births beyond 28 weeks of gestational age to the total number of FET cycles | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | number of cases with observed gestational sac with embryonic heartbeat detected by ultrasound two weeks after positive pregnancy to the totoal number of frozen embryo transfer cycles. | 2 weeks after positive pregnancy test | 
| Implantation rate | proportion of the number of gestational sacs to the number of embryos transferred | 2 weeks after positive pregnancy test | 
| Miscarriage rate | number of lost before the 20th week of gestation to the number of clinical pregnancies | 20 weeks gestational age |