To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation

Peking University

Status and phase: Unknown; Phase 2

Conditions: Infertility

Treatments: Drug: Luveris

Study type: Interventional

Funder types: Other

Identifiers

NCT01029470

EMR700642-606

Details and patient eligibility

About

Primary objective:

To evaluate the efficacy in terms of oocyte retrieval number of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation.

Secondary objective:

To further explore the efficacy of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation To evaluate the safety of rLH supplementation in hyporesponse women

Full description

Primary endpoint:

Number of oocyte retrieved

Secondary endpoints:

1. Oestrodial on hCG day (pg/ml)
2. Number of embryos
3. Implantation rate (%)
4. Clinical pregnancy rate (%)
5. Ongoing PR per IVF cycle (%)
6. Abortion rate (%)
7. Ampoules of rFSH
8. FertiQoL score Safety endpoint: adverse events

Enrollment: 150 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 20-40 years old women
2. With menstrual cycles ranged 24-35 days, intraindividual variability±3 days
3. Basal FSH <10 IU/L at cycle D2-D5
4. 18 < BMI < 30
5. Presence of two ovaries
6. No ovarian stimulation over the past 3 months
7. Signed inform consent form.

Exclusion criteria

1. Polycystic ovarian syndrome
2. rAFS stage Ⅲ-Ⅳ endometriosis
3. Chromosomal abnormalities, endocrinological and/or autoimmune disorders.
4. More than two previously unsuccessful IVF.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Luveris

Experimental group

Description:

Those subjects who experience hyponresponse to FSH stimulation during mid-follicle phase after pituitary downregulation will receive Luveris 75IU or 150IU IH injection daily till HCG day.

Treatment:

Drug: Luveris