Repeated Implantation FailureNCT03445910
Intrauterine Injection of Human Chorionic Gonadotrophin and Pregnancy Rate in ICSI
A study testing Human chorionic gonadotropin in people with Repeated Implantation Failure, run by Ain Shams University at 1 site in Egypt.
Trial summary
Despite recent advances in clinical and laboratory techniques of Assisted Reproductive Technology (ART), the pregnancy rate remains around 30% per cycle. It has been estimated that 50% to 75% of lost pregnancies are due to failure of implantation. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Repeated Implantation Failure
- What is being tested?
- Human chorionic gonadotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2018to 30 Jul 2018
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- A- Age between 20 and 35 years old.
- B- Patients undergoing ICSI trial after one or more previous failure.
Who cannot join
- A- Females with any local cause, uterine pathology, e.g: uterine myoma or previous myomectomy, endometriosis or the presence of hydrosalpinges.
- B- Patients undergoing ICSI trial for the first time.
- C- Previous Asherman Syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Implantation and Pregnancy Rates in Intracytoplasmic Sperm Injection: a Prospective Randomized Study
Despite recent advances in clinical and laboratory techniques of Assisted Reproductive Technology (ART), the pregnancy rate remains around 30% per cycle. It has been estimated that 50% to 75% of lost pregnancies are due to failure of implantation.
The process of implantation is a locally controlled paracrine/juxtacrine-mediated phenomenon. Successful implantation depends on the synchronized "cross-talk" between a functional blastocyst and a "receptive" endometrium. This process leads to apposition, attachment and invasion of embryos and subsequent normal placentation. So the objective of this study is investigate the impact of intrauterine injection of human chorionic gonadotropin (hCG) at the day of ovum pick-up on implantation and pregnancy rates in patients with recurrent implantation failure.
Read the detailed description
The endometrium can only support implantation during a discrete period of about 6 to 9 days after LH peak; termed the "window of implantation". During this period endometrial glandular epithelium is differentiated into a highly secretory state with the production of various cytokines and growth factors that facilitate implantation. In fact, several substances secreted from the embryo or the endometrium affect implantation. These include cyclic adenosine monophosphate, relaxin, gonadotropin, prostaglandin E2, and glycoprotein hormones.
Human chorionic gonadotropin (hCG) is the earliest blastocyst-derived signals received by the endometrium; it is transcribed as early as the 2-cell embryo stage. It is produced by the trophectodermal cells of the preimplantation blastocyst. Recent evidence suggests that hCG is also produced by the endometrial epithelial cells during the secretory.
It has been shown that intrauterine injection of hCG before embryo transfer significantly improves pregnancy rates in IVF/ICSI cycles.
- Conditions
- Repeated Implantation Failure
- Being tested
- Human chorionic gonadotropin
- Keywords
- human chorionic gonadotropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human chorionic gonadotropinDrug
Also called Chorimone, pregnyl
intrauterine injected of 500 IU of hCG on the day of ovum pick-up and
| Study group | Role | What they receive |
|---|---|---|
| Human chorionic gonadotrophin | Experimental | The hCG Group included 50 patients who had an intrauterine injected of 500 IU of hCG on the day of ovum pick-up Receives: Drug: Human chorionic gonadotropin |
| control | No intervention | The Control Group included 50 patients who went through the ICSI conventional protocol without intrauterine injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate
is defined as the number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of embryos transferred
Measured: six weeks from the last menstrual period
Secondary outcomes (2)
biochemical pregnancy
defined as positive from quantitative values of serum test of β human chorionic gonadotropin according to standard values that are used in the laboratory.
Measured: two weeks following embryo transfere
clinical pregnancy
is defined as viable pregnancy when there is evidence of gestational sac, embryo and fetal heart activity at time of trans-vaginal ultrasound evaluation by the 8th week.
Measured: eight weeks from last menstrual period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start20 Feb 2018
- Primary completion1 Jun 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repeated Implantation FailureStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayam Fathy Mohammad, Ain Shams University
- Investigators
- Hayam F Mohammad, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445910
- Sponsor's protocol ID
- 3
- Status last verified
- Aug 2018
- First submitted
- 21 Feb 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Implantation and Pregnancy Rates in Intracytoplasmic Sperm Injection: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03445910
- Acronym / sponsor ID
- 3
- Conditions
- Repeated Implantation Failure
- Keywords
- human chorionic gonadotropin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 26 Feb 2018 (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.
Despite recent advances in clinical and laboratory techniques of Assisted Reproductive Technology (ART), the pregnancy rate remains around 30% per cycle. It has been estimated that 50% to 75% of lost pregnancies are due to failure of implantation.
The process of implantation is a locally controlled paracrine/juxtacrine-mediated phenomenon. Successful implantation depends on the synchronized "cross-talk" between a functional blastocyst and a "receptive" endometrium. This process leads to apposition, attachment and invasion of embryos and subsequent normal placentation. So the objective of this study is investigate the impact of intrauterine injection of human chorionic gonadotropin (hCG) at the day of ovum pick-up on implantation and pregnancy rates in patients with recurrent implantation failure.
Detailed description
The endometrium can only support implantation during a discrete period of about 6 to 9 days after LH peak; termed the "window of implantation". During this period endometrial glandular epithelium is differentiated into a highly secretory state with the production of various cytokines and growth factors that facilitate implantation. In fact, several substances secreted from the embryo or the endometrium affect implantation. These include cyclic adenosine monophosphate, relaxin, gonadotropin, prostaglandin E2, and glycoprotein hormones.
Human chorionic gonadotropin (hCG) is the earliest blastocyst-derived signals received by the endometrium; it is transcribed as early as the 2-cell embryo stage. It is produced by the trophectodermal cells of the preimplantation blastocyst. Recent evidence suggests that hCG is also produced by the endometrial epithelial cells during the secretory.
It has been shown that intrauterine injection of hCG before embryo transfer significantly improves pregnancy rates in IVF/ICSI cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human chorionic gonadotrophin | Experimental | Drug: Human chorionic gonadotropinThe hCG Group included 50 patients who had an intrauterine injected of 500 IU of hCG on the day of ovum pick-up |
| control | No intervention | –The Control Group included 50 patients who went through the ICSI conventional protocol without intrauterine injection. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- A- Age between 20 and 35 years old.
- B- Patients undergoing ICSI trial after one or more previous failure.
Key exclusion criteria (3 listed)
- A- Females with any local cause, uterine pathology, e.g: uterine myoma or previous myomectomy, endometriosis or the presence of hydrosalpinges.
- B- Patients undergoing ICSI trial for the first time.
- C- Previous Asherman Syndrome.
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 |
|---|---|---|
| Human chorionic gonadotropinAlso: Chorimone, pregnylintrauterine injected of 500 IU of hCG on the day of ovum pick-up and | Drug | Human chorionic gonadotrophin |
Primary outcome
implantation rate
Time frame: six weeks from the last menstrual period
is defined as the number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of embryos transferred
2 secondary outcomes
biochemical pregnancy
Time frame: two weeks following embryo transfere
clinical pregnancy
Time frame: eight weeks from last menstrual 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 14 Aug 2018.
- Individual participant dataSharing planned: No
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Implantation Failure
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.
Hayam F Mohammad, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human chorionic gonadotropin in people with Repeated Implantation Failure, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 3 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 14 Aug 2018. 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 Egypt. 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?
implantation rate (time frame: six weeks from the last menstrual period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2018.