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

NCT01029470 | Unknown Phase 2

• 1 other identifier: EMR700642-606
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infertility

Keywords

Luveris; hyporesponse; pituitary downregulation; IVF; Infertility women

Outcome Measures

Primary Outcomes (1)

• Number of oocyte retrieved

  2009Dec-2010Oct

Secondary Outcomes (8)

• 1. Oestrodial on hCG day (pg/ml) Safety: adverse events

  2009 Dec-2010 Oct

• 2. Number of embryos

  2009 Dec-2010 Oct

• 3. Implantation rate (%)

  2009 Dec-2010 Oct

• 4. Clinical pregnancy rate (%)

  2009 Dec-2010 Oct

• 5. Ongoing PR per IVF cycle (%)

  2009 Dec-2010 Oct

Study Arms (1)

Luveris

EXPERIMENTAL

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.

Drug: Luveris

Interventions

Luveris DRUG

Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day

Also known as: Gonal-f, ovidrel

Luveris

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking Union Medical College Hospital: collaborator
• Chongqing Medical Center for Women and Children: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Reproductive & Genetic Hospital of CITIC-Xiangya: collaborator

Study Sites (1)

Peking University third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Infertility

Interventions

Luteinizing Hormone, beta Subunit; follitropin alfa; Ovidrel

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Luteinizing Hormone; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jie Qiao, MD, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Qiao, MD, PHD

CONTACT

86-10-82266699; qiaojiebu3h@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2011
• Last Updated: December 10, 2009

Record last verified: 2009-12

Locations

CN (1)