Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles

Study Overview
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Brief Summary
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This study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with frozen embryo transfer. The study population in frozen embryo transfer cycles receive three doses of human chorionic gonadotropin (HCG) to recognize the effectiveness of HCG on pregnancy outcomes in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

Detailed Description
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During implantation, the biochemical crosstalk between the endometrium and embryo has a very important role. The endometrium secrets cytokines and growth factors that modulate embryonic differentiation and early development. One of the important molecular messages between the embryo and endometrium is human chorionic gonadotropin (HCG). HCG is expressed by the blastocyst before the implantation, while increasingly produced after implantation by the syncytiotrophoblast. In order to study the direct effect of HCG on the endometrium at implantation, this randomized, controlled clinical trial evaluated whether HCG supplementation would be beneficial for pregnancy outcomes of cryopreserved-thawed embryo transfer with estrogen/ progesterone replacement cycles at Royan Institute. Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 6. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 200 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope.

Official Title
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The Effect of Intramuscular Injection of Triple Doses of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles

Conditions
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Embryo Implantation

Intervention / Treatment
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* Drug: The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile women candidates for frozen embryo transfer Age 20-40 years Body Mass Index under than 30 Kg/m2 Having at least three good quality embryos Exclusion Criteria: Women with hematologic and autoimmune disorders Couples with chromosomal and genetic abnormalities Women with uterine anomalies Women with uterine and ovaries surgical history Women with endometriosis and adenomyosis Women with hydrosalpinx Women with uterine fibroids Women with history of recurrent abortion or recurrent implantation failure Severe male factor infertility (azoospermia) Embryo donation cycle Endometrial thickness less than 8 millimeter on the day of embryo transfer

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: The group of frozen embryo transfer with intramuscular injection of human chorionic gonadotropin.<br>In this group, endometrial preparation for embryo transfer will be through the standard protocol using a gonadotropin-releasing hormone agonist. Patients receive 5,000 IU of human chorionic gonadotropin by intramuscular injection, 72 hours before embryo transfer, on the day of embryo transfer, and 72 hours after embryo transfer. | Drug: The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles<br>* Patients receive 5,000 IU of human chorionic gonadotropin by intramuscular injection, 72 hours before embryo transfer, on the day of embryo transfer, and 72 hours after embryo transfer.<br>* Other names: The effect of intramuscular injection of triple doses of human chorionic gonadotropin on embryo implantation;|
| No Intervention: The group of frozen embryo transfer without intramuscular injection of human chorionic gonadotropin.<br>In this group, endometrial preparation for embryo transfer will be through the standard protocol using a gonadotropin-releasing hormone agonist. Embryo transfer will be done without human chorionic gonadotropin intramuscular injection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | The ratio of total number of observed gestational sacs to total number of transferred embryos. | 4 weeks after embryo transfer | 
| Ongoing pregnancy | Continued pregnancy at gestational week 12 or more per initiated cycle. | 12 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | Live birth is defined in which a live fetus is delivered beyond 20 completed weeks of gestational. | at least 20 weeks after embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human chorionic gonadotropin, frozen embryo transfer, infertility, assisted reproduction technology, estrogen/ progesterone replacement cycles