Synchronization of Follicle Wave Emergence and Ovarian Stimulation

NCT00439829 | Completed Phase 4

• 2 other identifiers: BIO-REB 06-03HlthCanadaFile#9427-U0208-47C
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.

Conditions

Infertility

Keywords

follicle; ovary; poor responder; stimulation; follicle wave emergence

Outcome Measures

Primary Outcomes (2)

• number of follicles greater than or equal to 15 mm on day of hCG

  March 2009

• peak serum estradiol concentrations

  March 2009

Secondary Outcomes (9)

• number of antral follicles (day 1 or day 4)

  March 2009

• number of follicles aspirated

  March 2009

• number of oocytes obtained

  March 2009

• oocyte morphology

  March 2009

• fertilization rates

  March 2009

Study Arms (2)

1

EXPERIMENTAL

Initiation of ovarian stimulation therapy on day 1 (i.e., first day of menses)

Drug: Gonal F; Drug: Luveris; Drug: Cetrotide; Drug: hCG

2

ACTIVE COMPARATOR

Initiation of ovarian stimulation therapy on day 4 (day 1= first day of menses)

Drug: Gonal F; Drug: Luveris; Drug: Cetrotide; Drug: hCG

Interventions

Gonal F DRUG

* 450 IU Gonal-f (Serono Canada) subcutaneously daily (225 IU BID; injections to be given after bloodwork). * Dosing to begin on day 1 or day 4 (day 1=first day of menses), continuing until administration of human Chorionic Gonadotropin (hCG; see below). * Gonal-f dose may be further reduced, at the discretion of the study physician, to minimize the risk of OHSS.

1; 2

Luveris DRUG

* 0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met: * leading follicle is \> 13 mm in diameter * if 6 or more follicles develop to \> 10 mm and E2 \> 1000 pmol/L * Dosing to continue until administration of hCG (see below).

1; 2

Cetrotide DRUG

* 0.250 mg Cetrotide (Serono Canada) and 75 IU Luveris (Serono Canada) subcutaneously daily when one or more of the following conditions are met: * leading follicle is \> 13 mm in diameter * if 6 or more follicles develop to \> 10 mm and E2 \> 1000 pmol/L * Dosing to continue until administration of hCG (see below).

1; 2

hCG DRUG

\- 10,000 IU hCG (Pharmaceutical Partners of Canada Inc.) subcutaneously when: o \> 3 follicles are \> 17 mm in diameter

1; 2

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent obtained
• Age of 43 years or younger
• \< BMI \< 35
• History of poor response to ovarian stimulation as determined by:
• previously cancelled oocyte retrieval procedure due to \< 4 follicles greater than 12 mm on ultrasound OR
• \< 3 mature oocytes
• Physical exam performed within the past 12 months
• Normal or corrected levels of TSH and Prolactin within the past 12 months
• Has not taken ovarian suppression therapy within 1 month of initiating study drug

You may not qualify if:

• Chronic medical conditions such as renal failure
• Documented ovarian failure
• Presence of only one ovary
• Serum Day 3 FSH \> 12 IU/L within the past 6 months
• Ovaries inaccessible transvaginally
• Concomitant glucocorticoid use
• Ongoing pregnancy
• Any contraindications to ovarian stimulation treatment
• Participation in an investigational drug trial in the 30 days prior to the pre-study visit

Sponsors & Collaborators

• University of Saskatchewan: lead
• Royal University Hospital Foundation: collaborator

Study Sites (2)

Genesis Fertility Centre

Vancouver, British Columbia, V5Z 3X7, Canada

Location

Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan

Saskatoon, Saskatchewan, S7N0W8, Canada

Location

Related Publications (3)

• Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22. doi: 10.1016/s0015-0282(03)00544-2.

  PMID: 12849812 BACKGROUND

• Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. doi: 10.1095/biolreprod.103.017772. Epub 2003 May 14.

  PMID: 12748128 BACKGROUND

• Baerwald A, Anderson P, Yuzpe A, Case A, Fluker M. Synchronization of ovarian stimulation with follicle wave emergence in patients undergoing in vitro fertilization with a prior suboptimal response: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):881-7.e1-2. doi: 10.1016/j.fertnstert.2012.06.051. Epub 2012 Jul 20.

  PMID: 22819187 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa; Luteinizing Hormone, beta Subunit; cetrorelix

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

• Angela R Baerwald, PhD

  Dept OB/GYN, University of Saskatchewan

  STUDY DIRECTOR

• Allison M Case, MD FRCSC

  Dept OB/GYN, University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 26, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 25, 2010

Record last verified: 2010-05

Locations

CA (2)