NCT02264847

Brief Summary

In women being treated with medicines to help eggs to grow (called ovulation induction), The investigators wish to know whether adding medicines (called ovulation triggers) that help to release the egg (ovulation) would lead to more women having babies without causing harm compared with not giving them ovulation triggers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

October 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

2.5 years

First QC Date

October 4, 2014

Last Update Submit

February 7, 2017

Conditions

Ovulation Disorder

Keywords

Clomiphene CitrateOvulation triggerHuman chorionic gonadotrophin

Outcome Measures

Primary Outcomes (1)

  • Ovulation rate

    Collapse of the leading follicle with irregular shape, Appearance of the corpus luteum with diffuse internal echoes. Presence of fluid in the pouch of Douglas or hyperechoic endometrium were taken as supporting features. Serum progesterone levels of more than 10 ng/mL were considered to be evidence of ovulation.

    1 year

Secondary Outcomes (2)

  • chemical pregnancy

    1 year

  • Clinical pregnancy

    1 year

Study Arms (2)

Clomiphene citrate plus hCG

ACTIVE COMPARATOR

Women will receive clomiphene citrate from day 2 to day 6 of the cycle with a starting dose of 100 mg daily. If no response could be observed, the daily dose of clomiphene citrate in subsequent cycles will be increased by 50 mg until a response will be obtained or a maximum daily dose 200 mg of clomiphene citrate will be used. Once a follicle will reach more than 18 mm in size . Women will receive 5,000 IU human chorionic gonadotrophin trigger in the morning between 9 and 10 a.m. and the couple will be advised to have intercourse the following night, about 36 hours later.

Drug: Human chorionic gonadotrophin

Clomiphene Citrate alone

ACTIVE COMPARATOR

Women will receive clomiphene citrate from day 2 to day 6 of the cycle with a starting dose of 100 mg daily. If no response will be observed, the daily dose of clomiphene citrate in subsequent cycles will be increased by 50 mg until a response will be obtained or a maximum daily dose 200 mg of clomiphene citrate will be used. Once a follicle will reach more than 18 mm in size , the women will be advised to have intercourse frequently over the next few days.

Drug: clomiphene citrate alone

Interventions

Human chorionic gonadotrophinDRUG

Once a follicle reached more than 18 mm in size,women assigned to group (1) received 5,000 IU hCG trigger in the morning between 9 and 10 a.m. and the couple were advised to have intercourse the following night, about 36 hours later.

Also known as: hCG
Clomiphene citrate plus hCG
clomiphene citrate aloneDRUG

clomiphene citrate alone without hCG trigger

Clomiphene Citrate alone

Eligibility Criteria

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

You may qualify if:

  • Normoprolactinemic and normogonadotropic (WHO class II ovarian dysfunction )
  • Primary infertility with oligomenorrhea (bleeding intervals between 35 days and 6 months) or amenorrhea (bleeding interval more than 6 months)
  • Age 18-40 years
  • Duration of primary infertility more than2 years
  • No history of ovulation induction treatment
  • No history of thyroid disease
  • Normal results on hysterosalpingogram
  • Husband with normal semen analysis

You may not qualify if:

  • Ovarian cyst
  • Endometrioma
  • Liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine , Cairo University

Cairo, Cairo Governorate, 12311, Egypt

RECRUITING

Related Publications (1)

  • George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;2014(1):CD006900. doi: 10.1002/14651858.CD006900.pub3.

    PMID: 24482059BACKGROUND

MeSH Terms

Interventions

Chorionic GonadotropinClomiphene

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteinsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Waleed El-khyatat, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Waleed EL-khayat, M.D.

CONTACT

01005135542waleed_elkhyat@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetrics & Gynecology

Study Record Dates

First Submitted

October 4, 2014

First Posted

October 15, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

EG(1)