Study of the Cleavage of the Egg in Relation to the Stimulation Treatment

NCT ID: NCT01674894

Last Updated: 2017-08-28

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

COMPLETED

Total Enrollment

356 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-03-10

Brief Summary

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This post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.

Detailed Description

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Conditions

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Female Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Women treated with Menopur

No interventions assigned to this group

Group 2

Women treated with Menopur and Bravelle

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. IVF/ICSI treatment
2. Regular cycles of 25-35 days
3. Follicle stimulation with Bravelle and/or Menopur
4. Women aged 38-35 years
5. Long agonist or short antagonist treatment
6. Willing and able to understand a Danish, English or German patient information form
7. Willing and able to provide written Informed Consent

Exclusion Criteria

1. BMI more than 35
2. Presence of hydrosalpinx on ultrasound
3. FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
4. Known allergic reactions to the planned medications
5. Use of testicular sperm
Minimum Eligible Age

38 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Danish Fertility Clinic

Frederiksberg, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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000063

Identifier Type: -

Identifier Source: org_study_id

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