Stimulated Intrauterine Insemination Cycles and Unstimulated Intrauterine Insemination Cycles in Couples With Unexplained Infertility

NCT02461173 | Unknown Phase 3 DMC

• 1 other identifier: sub 10
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief Summary

Four hundred and fifty women with unexplained infertility will be divided into 3 equal groups using computer generated random numbers: Group 1 will have up to 4 stimulated 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 6 months

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Number of participants with ongoing pregnancy

  confirmation of a viable pregnancy by detecting fetal heart beat during abdominal ultrasound examination

  12 weeks after IUI or timed sexual intercourse

Study Arms (3)

Stimulated IUI

ACTIVE COMPARATOR

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 3nd 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; Procedure: IUI; Drug: Choriomon; Device: shepherd catheter

Unstimulated IUI

ACTIVE COMPARATOR

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; Procedure: Ovulation detection; Device: shepherd catheter

Control group

ACTIVE COMPARATOR

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

Interventions

Merional DRUG

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.

Stimulated IUI

IUI PROCEDURE

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

Stimulated IUI; Unstimulated IUI

Ovulation detection PROCEDURE

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

Control group; Unstimulated IUI

Choriomon DRUG

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

Stimulated IUI

shepherd catheter DEVICE

Stimulated IUI; Unstimulated IUI

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Unexplained infertility

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

BeniSuef University hospitals

BeniSuef, Egypt

RECRUITING

Cairo university hospitals

Cairo, Egypt

RECRUITING

Related Publications (3)

• Brandes M, Hamilton CJ, van der Steen JO, de Bruin JP, Bots RS, Nelen WL, Kremer JA. Unexplained infertility: overall ongoing pregnancy rate and mode of conception. Hum Reprod. 2011 Feb;26(2):360-8. doi: 10.1093/humrep/deq349. Epub 2010 Dec 16.

  PMID: 21163857 BACKGROUND

• Cooper TG, Noonan E, von Eckardstein S, Auger J, Baker HW, Behre HM, Haugen TB, Kruger T, Wang C, Mbizvo MT, Vogelsong KM. World Health Organization reference values for human semen characteristics. Hum Reprod Update. 2010 May-Jun;16(3):231-45. doi: 10.1093/humupd/dmp048. Epub 2009 Nov 24.

  PMID: 19934213 BACKGROUND

• Quintero RB, Urban R, Lathi RB, Westphal LM, Dahan MH. A comparison of letrozole to gonadotropins for ovulation induction, in subjects who failed to conceive with clomiphene citrate. Fertil Steril. 2007 Oct;88(4):879-85. doi: 10.1016/j.fertnstert.2006.11.166.

  PMID: 17920403 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

hMG-IBSA; Ovulation Detection

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ovarian Function Tests; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gynecology and Obstetrics

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 3, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2017
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

EG (2)