Human Chorionic Gonadotrophin & Trigger

NCT ID: NCT02264847

Last Updated: 2017-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Women will be treated with clomiphene citrate to help eggs to develop to additionally receive a medicine (urinary hCG) to trigger their release or to receive no additional treatment. the investigators tried to determine the benefits and harms of administering an ovulation trigger to anovulatory women receiving treatment with ovulation-inducing agents in comparison with spontaneous ovulation following ovulation induction. so we will have comparison between 2 groups, group 1 will receive clomiphene citrate and trigger ovulation by human chorionic gonadotrophin and group 2 will receive clomiphene citrate with no drug to trigger ovulation.

Conditions

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Ovulation Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Clomiphene citrate plus hCG

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.

Group Type ACTIVE_COMPARATOR

Human chorionic gonadotrophin

Intervention Type DRUG

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.

Clomiphene Citrate alone

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.

Group Type ACTIVE_COMPARATOR

clomiphene citrate alone

Intervention Type DRUG

clomiphene citrate alone without hCG trigger

Interventions

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Human chorionic gonadotrophin

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.

Intervention Type DRUG

clomiphene citrate alone

clomiphene citrate alone without hCG trigger

Intervention Type DRUG

Other Intervention Names

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hCG

Eligibility Criteria

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Inclusion Criteria

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

\-

Exclusion Criteria

1. Ovarian cyst
2. Endometrioma
3. Liver disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Waleed El-khayat

Assistant Professor of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed El-khyatat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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faculty of medicine , Cairo University

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Waleed EL-khayat, M.D.

Role: CONTACT

01005135542 ext. +2

Facility Contacts

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Waleed M El-khayat, M.D.

Role: primary

0105135542 ext. +2

Waleed El-khayat, M.D.

Role: backup

01005135542 ext. +2

References

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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.

Reference Type BACKGROUND
PMID: 24482059 (View on PubMed)

Other Identifiers

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A5102014

Identifier Type: OTHER

Identifier Source: secondary_id

5102014

Identifier Type: -

Identifier Source: org_study_id

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