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Human Chorionic Gonadotrophin & Trigger

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ClinicalTrials.gov Identifier: NCT02264847
Recruitment Status : Unknown
Verified February 2017 by Waleed El-khayat, Cairo University.
Recruitment status was:  Recruiting
First Posted : October 15, 2014
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University

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.

Condition or disease Intervention/treatment Phase
Ovulation Disorder Drug: Human chorionic gonadotrophin Drug: clomiphene citrate alone Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Trigger or Not to Trigger? : An Answer for an Old Question
Study Start Date : October 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.
Other Name: hCG

Active Comparator: 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.
Drug: clomiphene citrate alone
clomiphene citrate alone without hCG trigger




Primary Outcome Measures :
  1. Ovulation rate [ Time Frame: 1 year ]

    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.



Secondary Outcome Measures :
  1. chemical pregnancy [ Time Frame: 1 year ]
    A positive urine pregnancy test done 7 days after missing the period

  2. Clinical pregnancy [ Time Frame: 1 year ]
    demonstration of a fetal heart beat on transvaginal ultrasound between 6 and 7 weeks of gestation.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264847


Contacts
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Contact: Waleed EL-khayat, M.D. 01005135542 ext +2 waleed_elkhyat@yahoo.com

Locations
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Egypt
faculty of medicine , Cairo University Recruiting
Cairo, Egypt, 12311
Contact: Waleed M El-khayat, M.D.    0105135542 ext +2    waleed_elkhyat@yahoo.com   
Contact: Waleed El-khayat, M.D.    01005135542 ext +2    waleed_elkhyat@yahoo.com   
Principal Investigator: Waleed M El-Khayat, M.D.         
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Waleed El-khyatat, M.D. Cairo University

Publications:
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Responsible Party: Waleed El-khayat, Assistant Professor of Obstetrics & Gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT02264847     History of Changes
Other Study ID Numbers: 5102014
A5102014 ( Other Identifier: Cairo University )
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Keywords provided by Waleed El-khayat, Cairo University:
Clomiphene Citrate
Ovulation trigger
Human chorionic gonadotrophin
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators