NCT02787811

Brief Summary

Superovulation will be conducted with 100 mg of oral clomiphene citrate (Clomifene; Young Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon; FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of 17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge, 5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
completed

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

May 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

May 23, 2016

Last Update Submit

March 18, 2017

Conditions

Assisted Reproductive Techniques

Keywords

IUIPregnancy ratepredictors

Outcome Measures

Primary Outcomes (1)

  • chemical pregnancy rate

    14 days after IUI

Study Arms (2)

Pregnant

ACTIVE COMPARATOR

women with positive serum beta HCG done 14 days after Intrauterine insemenation

Device: Intrauterine insemenation

Nonpregnant

ACTIVE COMPARATOR

women with negative serum beta HCG done 14 days after Intrauterine insemenation

Device: Intrauterine insemenation

Interventions

Intrauterine insemenationDEVICE

Semen preparation processing hen intrauterine transfer after 24 hours of HCG triggering of ovulation

NonpregnantPregnant

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • These patients had at least 1 tube patent
  • there were no significant intrauterine or pelvic abnormalities demonstrated on pelvic-abdominal ultrasonography, hysteroscopy, and/or laparoscopy
  • serum follicular stimulating hormone (FSH) level of12 mIU/mL or less

You may not qualify if:

  • A woman's age of more than 40 years,
  • ovarian cyst detected in the ultrasound examination
  • uterine lesions such as submucosal leiomyoma, and a previous diagnosis of moderate to severe pelvic endometriosis.
  • women with body mass index \> 35 kg/m2,
  • PCOS/anovulatory patients
  • signs of hyperandrogenemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ahmed Maged, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 1, 2016

Study Start

May 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 21, 2017

Record last verified: 2017-03