An interventional study of The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles in Embryo Implantation, sponsored by Royan Institute. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Royan Institute · Not applicable, Interventional, and Treatment
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.
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 200 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Royan Institute is the lead sponsor of 94 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Also known as: The effect of intramuscular injection of triple doses of human chorionic gonadotropin on embryo implantation
Rate of Implantation
Implantation rate is the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.
Time frame: 6 weeks after embryo transfer
Plan to share: Yes — After the publication of the article Available to the public. Scientific use by citing the source. Request via e-mail
Supporting information: Clinical study report
Time frame: After the publication of the article
Access criteria: Available to the public. Scientific use by citing the source.
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Aug 2022, 25 months.
Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 25 months is close to that.
Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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