Female InfertilityNCT05050747
Study to Assess the Effect of Intrauterine Adminstration of HCG Versus Endometrial Injury by Pipelle
An observational study of Female Infertility, run by Wael Elbanna Clinic at 1 site in Egypt.
Trial summary
Our study aims to describe the effect of the intrauterine adminstration of HCG versus the endometrial injury by pipelle on the ongoing pregnancy rate and the biochemical pregnancy rate in women with unexplained infertility undergoing ovulation induction. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- HCG is introduced at day of trigger intra-uterine and endometrial injury by pipelle
- Type of treatment
- Medical device
- How many people
- 402 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Sep 2021to 12 Nov 2024
- Phase
- Observational
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will include women with unexplained infertility undergoing ovulation induction following either: 1. Intrauterine adminstration of HCG 2. Endometrial injury by pipelle 3. Intrauterine adminstration of placebo
Who may be able to join
- Women with primary or secondary infertility due to unexplained infertility
- The age group of these women was 25-35 years
- BMI 18.5-29.9 kg/m2
- Normal hormone profile (FSH <10 mIU/ml on day 2-3 and AMH more than 1)
- Euthyroid state or controlled thyroid state
- Bilateral free spill on HSG
Who cannot join
- Patients with severe male factor infertility; serum analysis count < 10 million sperms /mL - sperm motility<15% - 96%<abnormal morphology)
- Stage III or IV endometriosis
- Bilateral tubal factor infertility
- Premature ovarian failure
- Polycystic ovary syndrome
- Uterine cavity abnormality
- Recurrent spontaneous abortion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Prospective Controlled Study to Assess the Effect of Intrauterine Adminstration of HCG Versus Endometrial Injury by Pipelle on the Ongoing Pregnancy Rate in Patients with Unexplained Infertility Undergoing Ovulation Induction
Our study aims to describe the effect of the intrauterine adminstration of HCG versus the endometrial injury by pipelle on the ongoing pregnancy rate and the biochemical pregnancy rate in women with unexplained infertility undergoing ovulation induction. Also to describe the effect on the first trimester miscarriage rate, ectopic pregnancy rate, and multiple pregnancy.This study is an open-label, prospective, controlled study, multi-center study.
The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. The study materials that will be used will include blood tests, and ultrasound. The study will involve three study arms.
Read the detailed description
Our study aims to describe the effect of the intrauterine adminstration of HCG versus the endometrial injury by pipelle on the ongoing pregnancy rate and the biochemical pregnancy rate in women with unexplained infertility undergoing ovulation induction. Also to describe the effect on the first trimester miscarriage rate, ectopic pregnancy rate, and multiple pregnancy.This study is an open-label, prospective, controlled study, multi-center study.
The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. The study materials that will be used will include blood tests, and ultrasound. The study will involve three study arms:
Arm 1: Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger Arm 2: Women with unexplained infertility undergoing ovulation induction following endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction Arm 3: Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of placebo on the day of trigger
Primary and secondary key measurements will be used in the study.
The primary measures will include:
- Signs of ongoing pregnancy Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks
- Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy
The secondary key measures will include:
- Occurance of abortion in the 1st trimester
- Appearance of ectopic pregnancy diagnosis by:
Ultrasound Serum β-HCG level Symptoms of pain and bleeding
- Signs of multiple pregnancy Number of intrauterine gestational sacs Number of fetal poles Number of fetal heart pulsations
- Recording the the baseline characteristics of the study participants
- Conditions
- Female Infertility
- Being tested
- HCG is introduced at day of trigger intra-uterine, endometrial injury by pipelle
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCG is introduced at day of trigger intra-uterineDrug
hcg is introduced
endometrial injury by pipelleDevice
endometrial injury using pipelle on day 8-9 on the same cycle of ovulation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger Receives: Drug: HCG is introduced at day of trigger intra-uterine | |
| Arm 2 | Women with unexplained infertility undergoing ovulation induction following endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction Receives: Device: endometrial injury by pipelle | |
| Arm 3 | Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of placebo on the day of trigger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs of ongoing pregnancy
Recording the following for the three arms of the study:
- Signs of ongoing pregnancy Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks
- Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy
Measured: Till the end of the 1st trimester
Secondary outcomes (2)
occurance of abortion or ectopic or multiple pregnancy
Recording the following for the three arms of the study:
- Occurance of abortion in the 1st trimester
- Appearance of ectopic pregnancy diagnosis by:
Ultrasound Serum β-HCG level Symptoms of pain and bleeding
- Signs of multiple pregnancy Number of intrauterine gestational sacs Number of fetal poles Number of fetal heart pulsations
Measured: Till the end of the 1st trimester
Recording the baseline characteristics of the study participants
age , height , weight , body mass index
Measured: Before study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start27 Sep 2021
- Primary completion25 Aug 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wael Elbanna Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Principal investigator, Wael Elbanna, Wael Elbanna Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050747
- Sponsor's protocol ID
- Elbanna_002
- Status last verified
- Sep 2021
- First submitted
- 13 Aug 2021
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Prospective Controlled Study to Assess the Effect of Intrauterine Adminstration of HCG Versus Endometrial Injury by Pipelle on the Ongoing Pregnancy Rate in Patients with Unexplained Infertility Undergoing Ovulation Induction
- ClinicalTrials.gov ID
- NCT05050747
- Acronym / sponsor ID
- Elbanna_002
- Conditions
- Female Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Wael Elbanna ClinicUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 21 Sep 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.
Our study aims to describe the effect of the intrauterine adminstration of HCG versus the endometrial injury by pipelle on the ongoing pregnancy rate and the biochemical pregnancy rate in women with unexplained infertility undergoing ovulation induction. Also to describe the effect on the first trimester miscarriage rate, ectopic pregnancy rate, and multiple pregnancy.This study is an open-label, prospective, controlled study, multi-center study.
The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. The study materials that will be used will include blood tests, and ultrasound. The study will involve three study arms.
Detailed description
Our study aims to describe the effect of the intrauterine adminstration of HCG versus the endometrial injury by pipelle on the ongoing pregnancy rate and the biochemical pregnancy rate in women with unexplained infertility undergoing ovulation induction. Also to describe the effect on the first trimester miscarriage rate, ectopic pregnancy rate, and multiple pregnancy.This study is an open-label, prospective, controlled study, multi-center study.
The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. The study materials that will be used will include blood tests, and ultrasound. The study will involve three study arms:
Arm 1: Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger Arm 2: Women with unexplained infertility undergoing ovulation induction following endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction Arm 3: Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of placebo on the day of trigger
Primary and secondary key measurements will be used in the study.
The primary measures will include:
- Signs of ongoing pregnancy Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks
- Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy
The secondary key measures will include:
- Occurance of abortion in the 1st trimester
- Appearance of ectopic pregnancy diagnosis by:
Ultrasound Serum β-HCG level Symptoms of pain and bleeding
- Signs of multiple pregnancy Number of intrauterine gestational sacs Number of fetal poles Number of fetal heart pulsations
- Recording the the baseline characteristics of the study participants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Drug: HCG is introduced at day of trigger intra-uterineWomen with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger |
| Arm 2 | – | Device: endometrial injury by pipelleWomen with unexplained infertility undergoing ovulation induction following endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction |
| Arm 3 | – | –Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of placebo on the day of trigger |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will include women with unexplained infertility undergoing ovulation induction following either: 1. Intrauterine adminstration of HCG 2. Endometrial injury by pipelle 3. Intrauterine adminstration of placebo
Key inclusion criteria (6 listed)
- Women with primary or secondary infertility due to unexplained infertility
- The age group of these women was 25-35 years
- BMI 18.5-29.9 kg/m2
- Normal hormone profile (FSH <10 mIU/ml on day 2-3 and AMH more than 1)
- Euthyroid state or controlled thyroid state
Key exclusion criteria (7 listed)
- Patients with severe male factor infertility; serum analysis count < 10 million sperms /mL - sperm motility<15% - 96%<abnormal morphology)
- Stage III or IV endometriosis
- Bilateral tubal factor infertility
- Premature ovarian failure
- Polycystic ovary 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 |
|---|---|---|
| HCG is introduced at day of trigger intra-uterinehcg is introduced | Drug | Arm 1 |
| endometrial injury by pipelleendometrial injury using pipelle on day 8-9 on the same cycle of ovulation | Device | Arm 2 |
Primary outcome
Signs of ongoing pregnancy
Time frame: Till the end of the 1st trimester
Recording the following for the three arms of the study: * Signs of ongoing pregnancy Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks * Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy
2 secondary outcomes
occurance of abortion or ectopic or multiple pregnancy
Time frame: Till the end of the 1st trimester
Recording the baseline characteristics of the study participants
Time frame: Before study intervention
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 19 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Infertility, run by Wael Elbanna Clinic 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 6 inclusion and 7 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 19 Feb 2025. 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?
Signs of ongoing pregnancy (time frame: Till the end of the 1st trimester). 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 19 Feb 2025.