NCT02470169

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

June 9, 2015

Last Update Submit

January 20, 2017

Conditions

Subfertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy

    confirmation of an ongoing pregnancy by detecting fetal heart beat during abdominal ultrasound examination 12 weeks after IUI or timed sexual intercourse.

    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 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: MerionalProcedure: IUIDrug: ChoriomonDevice: 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: IUIDevice: shepherd catheterProcedure: Ovulation detection

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

MerionalDRUG

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
IUIPROCEDURE

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

Stimulated IUIUnstimulated IUI
ChoriomonDRUG

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 catheterDEVICE
Stimulated IUIUnstimulated IUI
Ovulation detectionPROCEDURE

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 groupUnstimulated IUI

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Endometriosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BeniSuef University hospitals

BeniSuef, Egypt

RECRUITING

Cairo university hospitals

Cairo, Egypt

RECRUITING

Related Publications (2)

  • Esmaeilzadeh S, Mirabi P, Basirat Z, Zeinalzadeh M, Khafri S. Association between endometriosis and hyperprolactinemia in infertile women. Iran J Reprod Med. 2015 Mar;13(3):155-60.

    PMID: 26000006BACKGROUND

  • 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: 17920403BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

hMG-IBSAOvulation Detection

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Ovarian Function TestsDiagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisReproductive TechniquesTherapeuticsInvestigative 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

June 9, 2015

First Posted

June 12, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

EG(2)