Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000568415
Ethics application status
Approved
Date submitted
27/10/2007
Date registered
5/11/2007
Date last updated
5/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effectiveness of Clomiphene Citrate In suppression of Luteinising Hormone (LH) Surge in Assisted Reproductive Technologies (ART): A randomized controlled pilot study
Scientific title
The effectiveness of Clomiphene Citrate compared to Human Menopausal Gonadotrophon on the suppression of Luteinising Hormone surges in women undergoing ovulation induction
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subfertile couples 2510 0
Mild male factor 2511 0
Condition category
Condition code
Reproductive Health and Childbirth 2607 2607 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Participants will receive a fixed dose of intramuscular/ subcutaneous Human Menopausal Gonadotropin (hMG) 75-150 IU per day starting from day 3 of the menstrual cycle for four days, then participants will receive oral Clomiphene Citrate (CC) till follicle reach 20mm
- All participants will undergo monitoring by ultrasound from day 8 and daily serum Luteinising Hormone (LH) when leading follicle is more than 15mm
- E2 assay will be done on day of Human Chorionic Gonadotropin (hCG)
- Progesterone will monitored on day 22
Intervention code [1] 2238 0
Prevention
Comparator / control treatment
- Participants will receive a fixed dose of intramuscular/ subcutaneous Human Menopausal Gonadotropin (hMG) 75-150 IU per day starting from day 3 of the menstrual cycle for four days, and continue on hMG till follicle reaches 20mm
Control group
Active

Outcomes
Primary outcome [1] 3519 0
LH surge
Timepoint [1] 3519 0
- First visit (clinical examination, medical history, determine inclusion/ exclusion criteria, patient signs the consent form and is randomized)
- Serum LH and adverse events will be determined and recorded at regular follow-up visits according to patient response
Secondary outcome [1] 5871 0
endometrial thickness on day of hCG
Timepoint [1] 5871 0
- Determined on the day of hCG administration

Eligibility
Key inclusion criteria
-mild male factor
-less than 39 years of age
- Normal uterus as documented by ultrasound (US) examination
- healthy females as documented by examination and laboratory tests
Minimum age
18 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Subfertility due to other causes
- Any significant cardiovascular, pulmonary, neurologic, allergic, hepatic or renal disease
- Any laboratory parameter clinically relevant outside the normal range
- No ovarian cyst formation >2cm prior to start of stimulation
- Women with Body Mass Index (BMI) > 30
- Women with Polycystic Ovary (PCO) Syndrome

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Couples fullfilling the inclusion/exclusion criteria will be recruited from the outpatient clinic. Participants consenting to be included in this trial will be randomised by opening consecutively numbered, sealed, opaque envelopes to determine the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated block randomization table will be used randomize patients. The resutls of the randomization scheme will be placed in numbered, dark, sealed envelopes. The randomization process and envelopes containing the treatment allocation will be prepared by a third party not directly involved with the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 638 0
Egypt
State/province [1] 638 0
Cairo

Funding & Sponsors
Funding source category [1] 2754 0
Self funded/Unfunded
Name [1] 2754 0
Hesham G. Al-Inany, MD, PhD
Country [1] 2754 0
Egypt
Primary sponsor type
Individual
Name
Hesham G. Al-Inany, MD, PhD
Address
97 El Manial Street, Cairo
Country
Egypt
Secondary sponsor category [1] 2488 0
None
Name [1] 2488 0
Address [1] 2488 0
Country [1] 2488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4688 0
Cairo University Ethical Committee
Ethics committee address [1] 4688 0
Cairo University, Cairo, Egypt
Ethics committee country [1] 4688 0
Egypt
Date submitted for ethics approval [1] 4688 0
Approval date [1] 4688 0
21/10/2007
Ethics approval number [1] 4688 0

Summary
Brief summary
Clomiphene citrate (CC) is traditionally given from the 3rd-5th day of the cycle for five days as an ovulation induction drug. The mechanism of CC in stimulating ovulation is unknown but is believed to be related to its anti-oestrogenic properties. As a feed back mechanism, it stimulates the secretion of follicle stimulating hormone (FSH). When serum estradiol reaches a certain level, an leutinizing hormone (LH) surge is released. Of the cycles stimulated by CC and or human menopausal gonadotrophin (hMG), an endogenous LH surge was observed in more than 15% of the patients shortly prior to the HCG injection. In animal experimental studies, CC prevented the positive effects of estradiol required to induce an LH surge.
In a recent pilot study by Branigan & Estes 2006, CC was able to suppress LH surge in human IVF. The hypothesis behind this study is that if CC is given after hMG, the anti-oestrogenic effect will suppress LH surge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28150 0
Address 28150 0
Country 28150 0
Phone 28150 0
Fax 28150 0
Email 28150 0
Contact person for public queries
Name 11307 0
Hesham G. Al-Inany, MD, PhD
Address 11307 0
97 El Manial Street, Cairo
Country 11307 0
Egypt
Phone 11307 0
(+20-2) 2368-8063
Fax 11307 0
Email 11307 0
[email protected]
Contact person for scientific queries
Name 2235 0
Hesham G. Al-Inany, MD, PhD
Address 2235 0
97 El Manial Street, Cairo
Country 2235 0
Egypt
Phone 2235 0
(+20-2) 2368-8063
Fax 2235 0
Email 2235 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe effectiveness of clomiphene citrate in LH surge suppression in women undergoing IUI: a randomized controlled trial2010https://doi.org/10.1016/j.fertnstert.2010.01.069
N.B. These documents automatically identified may not have been verified by the study sponsor.