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Stimulated Versus Un-stimulated Intrauterine Insemination Cycles in Women With Endometriosis

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ClinicalTrials.gov Identifier: NCT02470169
Recruitment Status : Unknown
Verified January 2017 by AbdelGany Hassan, Cairo University.
Recruitment status was:  Recruiting
First Posted : June 12, 2015
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Brief Summary:
Four hundred and fifty women with endometriosis will be divided into 3 equal groups using computer generated random numbers: Group 1 will have up to 4 stimulated intrauterine insemination (IUI) cycles, group 2 will have up to 4 unstimulated cycles, women who do not become pregnant after the 4 cycles in groups 1 and 2 will be advised to have regular intercourse at the expected time of ovulation. Group 3 will be the control group will be advised to have regular sexual intercourse at the time of ovulation for 4 months

Condition or disease Intervention/treatment Phase
Subfertility Drug: Merional Procedure: IUI Drug: Choriomon Device: shepherd catheter Procedure: Ovulation detection Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stimulated Versus Un-stimulated Intrauterine Insemination Cycles in Women With Endometriosis: A Randomized Controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Active Comparator: Stimulated IUI
On the 3rd day of menstruation women in group 1 will have a vaginal ultrasound and will receive daily intramuscular 150 IU of human menopausal gonadotropins starting from the 3rd day of menstruation. On day 8 the ultrasound will be repeated and serum E2 will be measured, hMG dose will be adjusted and continued and the frequency of ultrasound scans will be individualized. HMG will be stopped when at least 2 follicles measuring 18 mm are associated with serum E2 of 500-3000 Pg/mL, this was followed by the administration of 10000 IU of human chorionic gonadotropin
Drug: Merional
On the 3rd day of menstruation women will have a vaginal ultrasound and will receive daily intramuscular 150 IU of human menopausal gonadotropins (hMG, Merional ®, IBSA, Lugano, Switzerland) starting from the 3nd day of menstruation.

Procedure: IUI
Semen will be processed and drawn into a shepherd catheter attached to a 1 mL syringe and injected into the uterus

Drug: Choriomon
Administration of 10000 IU of human chorionic gonadotropin (hCG; Choriomon®, IBSA) when at least 2 follicles measuring 18 mm are observed during vaginal ultrasound and is associated with serum E2 of 500-3000 Pg/mL

Device: shepherd catheter
Active Comparator: Unstimulated IUI
Women in group 2 will be asked to test their morning urine specimen for luteinizing hormone daily starting 4 days before the expected day of ovulation. This will be done using a qualitative kit. IUI will be performed on the day after the surge in urinary excretion of luteinizing hormone.
Procedure: IUI
Semen will be processed and drawn into a shepherd catheter attached to a 1 mL syringe and injected into the uterus

Device: shepherd catheter
Procedure: Ovulation detection
Women will be asked to test their morning urine specimen for luteinizing hormone daily starting 4 days before the expected day of ovulation. This will be done using a qualitative kit

Active Comparator: Control group
Women will be asked to test their urine for luteinizing hormone by the same method as group 2. They will be asked to have an intercourse on the day after the surge in urinary excretion of luteinizing hormone and this will be repeated for 12 months.
Procedure: Ovulation detection
Women will be asked to test their morning urine specimen for luteinizing hormone daily starting 4 days before the expected day of ovulation. This will be done using a qualitative kit




Primary Outcome Measures :
  1. Ongoing pregnancy [ Time Frame: 12 weeks after IUI or timed sexual intercourse ]
    confirmation of an ongoing pregnancy by detecting fetal heart beat during abdominal ultrasound examination 12 weeks after IUI or timed sexual intercourse.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Endometriosis

Exclusion Criteria:

  • Known allergy to FSH
  • Diabetes
  • Hypertension
  • known cardiac, renal or liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470169


Locations
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Egypt
BeniSuef University hospitals Recruiting
BeniSuef, Egypt
Contact: Nesreen AA Shehata, MD    +2001227866337    nesoomar@yahoo.com   
Principal Investigator: Nesreen Shehata, Md         
Cairo university hospitals Recruiting
Cairo, Egypt
Contact: AbdelGany Hassan, MRCOG, MD    002 01017801604    abdelgany2@gmail.com   
Principal Investigator: AbdelGany MA Hassan, MRCOG, MD         
Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02470169     History of Changes
Other Study ID Numbers: sub 11
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Endometriosis
Infertility
Genital Diseases, Female
Genital Diseases, Male
Hormones
Chorionic Gonadotropin
Menotropins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Fertility Agents, Female
Fertility Agents