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

P

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)

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

Trial contacts and locations

1

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Central trial contact

Jie Qiao, MD, PHD

Data sourced from clinicaltrials.gov

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