Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation

Infertility Clinical Trial

Official title:

Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319708
• Other study ID #: 1234561
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 8, 2011
• Last updated: November 7, 2015
• Start date: March 2011
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGreece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• poor responders (age>40, previous POR, abnormal OR test)

• indication for IVF

• regular cycling patients

• BMI 19-35

Exclusion Criteria:

• contraindication for clomiphene citrate use or to GnRH agonists antagonists

• BMI > 35

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• mild ovarian stimulation
100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery
• conventional ovarian stimulation
300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses with GnRH agonist long protocol

Locations

Country	Name	City	State
Greece	3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit	Athens	Chaidari

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of oocytes (COCs)		at oocyte recovery	No
Secondary	Number/rate of participants whom the IVF cycle was cancelled		After the 1st week of ovarian stimulation, no oocytes at OR	No
Secondary	clinical pregnancy rate	Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention	6 weeks	No
Secondary	live birth		more than 20 weeks	No
Secondary	miscarriage		pregnancy loss before 20 weeks of gestation, after a positive pregnancy test	No
Secondary	stimulation characteristics	total dose of gonadotropins administered,	from start of stimulation until embryo transfer	No
Secondary	cancellation rate	when premature ovulation was evident by the loss of follicle(s) prior to oocyte recovery, and in cases where there were no oocytes retrieved or no embryos produced for transfer and in failed fertilization	from start of stimulation until ET	No