Embryo ImplantationNCT04855383
Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles
A study testing The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles in people with Embryo Implantation, run by Royan Institute at 1 site in Iran.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo Implantation
- What is being tested?
- The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- 1 Jul 2020to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intramuscular Injection of Triple Doses of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles
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.
Read the detailed description
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.
- Conditions
- Embryo Implantation
- Being tested
- The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles
- Keywords
- Human chorionic gonadotropin, frozen embryo transfer, infertility, assisted reproduction technology, estrogen/ progesterone replacement cycles
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cyclesDrug
Also called The effect of intramuscular injection of triple doses of human chorionic gonadotropin on embryo implantation
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.
| Study group | Role | What they receive |
|---|---|---|
| The group of frozen embryo transfer with intramuscular injection of human chorionic gonadotropin. | Experimental | 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. Receives: Drug: The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles |
| The group of frozen embryo transfer without intramuscular injection of human chorionic gonadotropin. | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Jul 2020
- Primary completion22 Aug 2022
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Embryo ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mehri Mashayekhi, M.D., Study director, Department of Endocrinology and Female Infertility, ACECR, Tehran, Iran.Azar Yahyaei, M.Sc., Principal investigator, Department of Endocrinology and Female Infertility, ACECR, Tehran, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855383
- Sponsor's protocol ID
- FET-HCG
- Status last verified
- Jan 2024
- First submitted
- 18 Apr 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of the article Available to the public. Scientific use by citing the source. Request via e-mail
Publications
Moridi M, Yahyaei A, Vesali S, Mashayekhi M. The Effect of Intramuscular Human Chorionic Gonadotropin on Endometrial Preparation in Frozen-Thawed Embryo Transfer: A Randomized Clinical Trial. Int J Fertil Steril. 2026 Jul 27;20(Suppl 1):17-23. doi: 10.22074/ijfs.2025.2054284.1828.
PubMed 42571060
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intramuscular Injection of Triple Doses of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT04855383
- Acronym / sponsor ID
- FET-HCG
- Conditions
- Embryo Implantation
- Keywords
- Human chorionic gonadotropin, frozen embryo transfer, infertility, assisted reproduction technology, estrogen/ progesterone replacement cycles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group of frozen embryo transfer with intramuscular injection of human chorionic gonadotropin. | Experimental | Drug: The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cyclesIn 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. |
| The group of frozen embryo transfer without intramuscular injection of human chorionic gonadotropin. | No intervention | –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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cyclesAlso: The effect of intramuscular injection of triple doses of human chorionic gonadotropin on embryo implantationPatients 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 group of frozen embryo transfer with intramuscular injection of human chorionic gonadotropin. |
Primary outcome
Rate of Implantation
Time frame: 6 weeks after embryo transfer
Implantation rate is the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 42571060Moridi M, Yahyaei A, Vesali S, Mashayekhi M. The Effect of Intramuscular Human Chorionic Gonadotropin on Endometrial Preparation in Frozen-Thawed Embryo Transfer: A Randomized Clinical Trial. Int J Fertil Steril. 2026 Jul 27;20(Suppl 1):17-23. doi: 10.22074/ijfs.2025.2054284.1828.
- Individual participant dataSharing planned: Yes. After the publication of the article Available to the public. Scientific use by citing the source. Request via e-mail
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehri Mashayekhi, M.D. study director
Department of Endocrinology and Female Infertility, ACECR, Tehran, Iran.
Azar Yahyaei, M.Sc. principal investigator
Department of Endocrinology and Female Infertility, ACECR, Tehran, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles in people with Embryo Implantation, run by Royan Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Implantation (time frame: 6 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04855383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.