Study to Assess the Effect of Intrauterine Adminstration of HCG Versus Endometrial Injury by Pipelle
NCT ID: NCT05050747
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
402 participants
OBSERVATIONAL
2021-09-27
2024-11-12
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arm 1
Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger
HCG is introduced at day of trigger intra-uterine
hcg is introduced
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
endometrial injury by pipelle
endometrial injury using pipelle on day 8-9 on the same cycle of ovulation
Arm 3
Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of placebo on the day of trigger
No interventions assigned to this group
Interventions
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HCG is introduced at day of trigger intra-uterine
hcg is introduced
endometrial injury by pipelle
endometrial injury using pipelle on day 8-9 on the same cycle of ovulation
Eligibility Criteria
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Inclusion Criteria
2. The age group of these women was 25-35 years
3. BMI 18.5-29.9 kg/m2
4. Normal hormone profile (FSH \<10 mIU/ml on day 2-3 and AMH more than 1)
5. Euthyroid state or controlled thyroid state
6. Bilateral free spill on HSG
Exclusion Criteria
2. Stage III or IV endometriosis
3. Bilateral tubal factor infertility
4. Premature ovarian failure
5. Polycystic ovary syndrome
6. Uterine cavity abnormality
7. Recurrent spontaneous abortion
25 Years
35 Years
FEMALE
No
Sponsors
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National Research Centre, Egypt
OTHER
Wael Elbanna Clinic
OTHER
Responsible Party
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Wael Elbanna
Managing director for Wael Elbanna Clinic
Locations
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Wael Elbanna Clinic
Cairo, , Egypt
Countries
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Other Identifiers
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Elbanna_002
Identifier Type: -
Identifier Source: org_study_id
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