Mild Stimulation Protocol Versus Microdose Gonadotropin-releasing Hormone Agonist Flare up Protocol in Poor Responders

NCT01213147 | Completed Phase 4 DMC

• 1 other identifier: 2063
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the progression in assisted reproductive technology (ART), the preferred protocol for poor responders is still controversial. The management of poor responders consists of 10% of ART cycles . The response to controlled ovarian hyperstimulation (COH) is lower regarding estradiol level , number of obtained oocytes , and fertilization , implantation and pregnancy rates in patients with low ovarian reserve . Furthermore , bad quality embryos are observed in these women more than normoresponders and the increase of cancellation rate and doses of gonadotropin administration are remarkable results in poor responders . Several criteria have introduced for poor responders , the main defect in the management of them is lack of specific definition .Several strategies are available to improve ART cycles outcome in poor responders. These modalities include using : high FSH dose , stop GnRH-agonist protocol , addition of growth hormone , transdermal testosterone , aromatase inhibitor , GnRH-antagonist and recombinant FSH ( r-FSH) ; while the improvement of pregnancy rate has been quite low. The most common used protocol for ovarian stimulation is microdose GnRH-agonist flare in poor responders .Some investigators concluded that the use of GnRH-agonist " even in lower doses , led to prolonged stimulation and increased the cost without improving IVF outcome. Furthermore this method increased LH , progesterone and androgen of serum in follicular phase , which caused deleterious effect on follicular growth and oocyte quality . Clomiphene citrate co-treatment with gonadotropin and antagonist are one of the recommended protocol in poor responders . Clomiphene citrate increases endogenous FSH versus agonist in microdose protocol. Decreasing the doses of used gonadotropin and duration of stimulation are its beneficial effects in COH cycle . The aim of this study was comparing CC/gonadotropin/antagonist and GnRH agonist flare protocols on IVF outcome in poor responders .

Conditions

Pregnancy

Keywords

Pregnancy; Clomiphene Citrate; Fertilization; Buserelin

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  until 12th gestational week

Secondary Outcomes (1)

• and implantation rate

  until 12th gestational week

Study Arms (2)

clomiphene citrate,pregnancy,poor responders

EXPERIMENTAL

Woman in clomiphene citrate arm are administered 100mg/day oral from day 3 of menstrual cycle until day 7 of cycle

Drug: clomiphene citrate

buserelin,pregnancy,poor responder

ACTIVE COMPARATOR

women in control arm are administered Buserelin buserelin 50 µg SC twice a day from cycle day 2 of menstrual cycle

Drug: buserelin

Interventions

clomiphene citrate DRUG

100 mg per day oral for 7 days

clomiphene citrate,pregnancy,poor responders

buserelin DRUG

50 µg Subcutaneous twice a day from cycle day 2 of menstrual cycle

buserelin,pregnancy,poor responder

Eligibility Criteria

• Age: 38 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with ≥38 years old
• women who had one or more previous failed IVF cycles in which three or fewer oocyte were been retrieved and/or serum E2 level on the day of hCG administration was ≤500 pg/ml were enrolled in this study

You may not qualify if:

• BMI \> 30
• endocrine disorders
• metabolic disorders
• history of ovarian surgery
• sever endometriosis
• sever male factor ( azospermia )

Sponsors & Collaborators

• Yazd Medical University: lead
• Yazd Research & Clinical Center for Infertility: collaborator

Study Sites (1)

Yazd Research and Clinical Center for Infertility

Yazd, Yazd Province, 8916877391, Iran

Location

MeSH Terms

Interventions

Clomiphene; Buserelin

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Mehri Mashayekhy, infertility fellowship

  Yazd Research and Clinical Centre for Infertility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 1, 2010
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: May 1, 2010
• Last Updated: October 1, 2010

Record last verified: 2010-09

Locations

IR (1)