Clinical trial NCT02333253: Delayed Start Versus Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase
Official title: Delayed Start vs Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Other Complications Associated With Artificial Fertilization
Keywords: poor responders
GnRH antagonist
Conventional protocol
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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 All patients were 35 years old ore more We exclude patient \>44ys ,AMH \<0.3ng/ml,FSH \>13, also patients of DM, endometriosis, general disease were excluded, any local uterine anomalies were excluded.

All patients received OCP for one cycle Then all had taken estradiol tablet 2 mg for one week prior to menses of the test cycle from Day 21 to day 28 Then we divide them into 2 groups US were done to exclude any cyst or follicle \>10mm 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 28 day after ET, TVS was done to confirm ongoing pregnancy by visualization of IU sac.

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, HCG,OPU, ET were done by same method and under same criteria, luteal support and follow were the same.

Eligibility criteria: Inclusion Criteria:

1 Poor responders 2. Age \>35 years

Exclusion Criteria:

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

Primary outcomes:
measure: oocyte retrieved number
timeFrame: Induction cycle an expected average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed M Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: