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

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
MENOPUR; GONAL-F
Sponsored by
Central Jutland Regional Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fertilitetsklinikken Sygehus ViborgRecruiting

Outcomes

Primary Outcome Measures

Circulatory levels of Estradiol on the day of hCG

Secondary Outcome Measures

Total number of follicles as well as the numbers of follicles <10mm, 10-14 mm, >14mm day during gonadotrophin treatment and at the end of stimulation prior to hCG injection
E2 per follicle >14 mm
Total number of oocytes retrieved
fertilization rate
serum hCG > 10 IU/l on day 12-14 after embryo transfer
implantation rate
transferable embryos
Clinical pregnancy rate
Ongoing pregnancy rate
embryo quality
Serum; LH, FSH, Androstenedione, Progesterone, hCG and Inhibin-B. Progesterone seven days after ET day
Intra follicular levels of; endocrine parameters
Endometrial thickness; hCG day (minus 0-2 days)
Total gonadotrophin dose administered

Full Information

First Posted
June 6, 2006
Last Updated
June 9, 2006
Sponsor
Central Jutland Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00334425
Brief Title
The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.
Official Title
The Effect of LH-Priming During Early Follicular Phase on Ovarian Response and Pregnancy Outcome in GnRHa Down-Regulated Women, Stimulated With Exogenous Gonadotrophins in IVF Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Central Jutland Regional Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MENOPUR; GONAL-F
Primary Outcome Measure Information:
Title
Circulatory levels of Estradiol on the day of hCG
Secondary Outcome Measure Information:
Title
Total number of follicles as well as the numbers of follicles <10mm, 10-14 mm, >14mm day during gonadotrophin treatment and at the end of stimulation prior to hCG injection
Title
E2 per follicle >14 mm
Title
Total number of oocytes retrieved
Title
fertilization rate
Title
serum hCG > 10 IU/l on day 12-14 after embryo transfer
Title
implantation rate
Title
transferable embryos
Title
Clinical pregnancy rate
Title
Ongoing pregnancy rate
Title
embryo quality
Title
Serum; LH, FSH, Androstenedione, Progesterone, hCG and Inhibin-B. Progesterone seven days after ET day
Title
Intra follicular levels of; endocrine parameters
Title
Endometrial thickness; hCG day (minus 0-2 days)
Title
Total gonadotrophin dose administered

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Humaidan, M.D.
Phone
+ 45 89 27 40 11
Email
peter.humaidan@sygehusviborg.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Humaidan, M.D.
Organizational Affiliation
Fertilitetsklinikken Sygehus Viborg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertilitetsklinikken Sygehus Viborg
City
Skive
ZIP/Postal Code
7800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Humaidan, M.D.
Phone
+ 45 89 27 40 11
Email
peter.humaidan@sygehusviborg.dk
First Name & Middle Initial & Last Name & Degree
Peter Humaidan, M.D.

12. IPD Sharing Statement

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

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