The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.

NCT ID: NCT00334425

Last Updated: 2006-06-13

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

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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To evaluate the effect of LH-activity supplementation during the early follicular phase in GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by comparing different combinations with HP-HMG and r-FSH.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MENOPUR; GONAL-F

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females between the ages of 18- 38 years (both included) at the time of randomisation
* Patients for whom treatment with gonadotrophins and GnRH agonist (long protocol) in IVF setting is considered appropriate according to the criteria of the participating centre
* Infertility for at least 1 year before randomisation (except for tubal infertility)
* A maximum of two previous consecutive unsuccessful IVF cycles (i.e. not resulting in an ongoing pregnancy
* 25- 34 days of menstruation cycle
* Body mass index (BMI) \< 29 kg/m2

Exclusion Criteria

* Any clinically significant systemic disease (e.g., insulin dependent diabetes)
* Endocrine or metabolic abnormalities (pituitary, adrenal, thyroid, pancreas, liver, or kidney) which can compromise participation in the study
* Any concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), prostaglandin inhibitors (NSAIDs, including aspirin) and psychotropic agents (phenothiazine's, major tranquillisers) at the time of study entry. Note: these medications are disallowed for the study duration.
* Presence of clinically significant uterine fibroids
* Undiagnosed vaginal bleeding
* Tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
* Pregnancy, lactation or contraindication to pregnancy - must be confirmed by negative urinary pregnancy test at randomisation
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Central Jutland Regional Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Peter Humaidan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fertilitetsklinikken Sygehus Viborg

Locations

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Fertilitetsklinikken Sygehus Viborg

Skive, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Peter Humaidan, M.D.

Role: CONTACT

+ 45 89 27 40 11

Facility Contacts

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Peter Humaidan, M.D.

Role: primary

+ 45 89 27 40 11

Other Identifiers

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1-2005

Identifier Type: -

Identifier Source: org_study_id