ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

Mild male factor

Condition category

Condition code

Reproductive Health and Childbirth

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]

Prevention

Comparator / control treatment

Control group

Active

Outcomes

Primary outcome [1]

LH surge

Timepoint [1]

- 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]

endometrial thickness on day of hCG

Timepoint [1]

- 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]

Egypt

State/province [1]

Cairo

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Hesham G. Al-Inany, MD, PhD

Address [1]

97 El Manial Street, Cairo

Country [1]

Egypt

Primary sponsor type

Individual

Name

Hesham G. Al-Inany, MD, PhD

Address

97 El Manial Street, Cairo

Country

Egypt

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Cairo University Ethical Committee

Ethics committee address [1]

Cairo University, Cairo, Egypt

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

Approval date [1]

21/10/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Hesham G. Al-Inany, MD, PhD

Address

97 El Manial Street, Cairo

Country

Egypt

Phone

(+20-2) 2368-8063

Fax

hesham@khosoba.com

Contact person for scientific queries

Name

Hesham G. Al-Inany, MD, PhD

Address

97 El Manial Street, Cairo

Country

Egypt

Phone

(+20-2) 2368-8063

Fax

hesham@khosoba.com

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

Source	Title	Year of Publication	DOI
Dimensions AI	The effectiveness of clomiphene citrate in LH surge suppression in women undergoing IUI: a randomized controlled trial	2010	https://doi.org/10.1016/j.fertnstert.2010.01.069

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically