Delayed Start Versus Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase

NCT02333253 | Completed Phase 3 DMC

• 1 other identifier: 11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

40 patients attending IVF center during 2013 \&2014 were fulfilling criteria of poor response and they failed to go through OPU as they gave \<3 mature follicles on a dose of 300U GN or more. All patients were revised for history, examinations and investigations, including age, type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC.

Conditions

Other Complications Associated With Artificial Fertilization

Keywords

poor responders; GnRH antagonist; Conventional protocol

Outcome Measures

Primary Outcomes (1)

• oocyte retrieved number

  Induction cycle an expected average of 4 weeks

Study Arms (2)

Delayed start protocol

ACTIVE COMPARATOR

First group received 300 U r FSH +150 U urinary GN from day 2 till day of HCG ,dose adjusted according to the response then 0.25 cetrotide S.c was added on when leading follicle reach \>12 mm, HCG was given only if we have at least 3 mature follicles \>14 mm and the leading one \>17mm then OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if \> 5miu/ML

Drug: cetrotide

conventional antagonist protocol

ACTIVE COMPARATOR

Second group were received cetrotide 0.25 mg s.c alone from day 2 to day 8then we initiate GN therapy by same initial GN dose (300FSH+150U urinary GN).same adjustment of dose were done and antagonist restarted when DF \>12mm, till day of HCG, OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if \> 5miu/ML

Drug: cetrotide

Interventions

cetrotide DRUG

0.25 cetrotide S.c was added on when leading follicle reach \>12 mm

Also known as: cetrorelix acetate

Delayed start protocol; conventional antagonist protocol

Eligibility Criteria

• Age: 35 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Poor responders 2. Age \>35 years

You may not qualify if:

• patient \>44ys ,
• AMH \<0.3ng/ml,
• FSH \>13, also
• patients of DM ,endometriosis ,general disease were excluded,
• any local uterine anomalies were excluded.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

Location

MeSH Terms

Interventions

cetrorelix

Study Officials

• Ahmed M Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: January 7, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

EG (1)