Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?

Study Overview
=================
Brief Summary
-----------------
During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is administered to trigger the final follicular maturation before oocyte retrieval, in an attempt to mimic the physiologic effects of LH. The hCG is administered when more than three follicles ≥17mm in mean diameter have developed. The time interval between hCG administration and oocyte retrieval is of critical importance since the time after luteinizing stimulus is a period of intense processes including the start of luteinization, expansion of cumulus cells and oocyte meiotic maturation. The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown that significantly more high quality embryos have been obtained with a prolonged hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be beneficial in improving oocyte quality and achieving optimal maturation. Currently there are no data on the effect of the time interval between hCG administration and oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to determine whether there is any difference in in vitro fertilization outcome when oocyte retrieval takes place at 36 h or 38 h following hCG administration

Conditions
-----------------
Subfertility

Intervention / Treatment
-----------------
* Procedure: Oocyte retrieval will be performed 36 h or 38 h after hCG administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women undergoing fresh IVF cycle with recombinant FSH and GnRH antagonists regular spontaneous menstrual cycle (24-35 days) age ≤ 43 years FSH ≤ 20 IU/L Exclusion Criteria: History of previous ovarian surgery Women with Stage III-IV Endometriosis Women undergoing natural cycle IVF

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 43 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 36 h group<br>Oocyte retrieval will be performed 36 hours after hCG administration | Procedure: Oocyte retrieval will be performed 36 h or 38 h after hCG administration<br>* Oocyte retrieval will be performed 36 h or 38 h after hCG administration<br>* Other names: oocyte retrieval at 38 hours following hCG administration;|
| Active Comparator: 38 h group<br>Oocyte retrieval will be performed 38 hours after hCG administration | Procedure: Oocyte retrieval will be performed 36 h or 38 h after hCG administration<br>* Oocyte retrieval will be performed 36 h or 38 h after hCG administration<br>* Other names: oocyte retrieval at 38 hours following hCG administration;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retrieval rate (cumulus-oocyte complexes/ follicles> 11 mm) |  | up to 38 h after hCG administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation) |  | At 6-8 weeks of gestation | 
| Total number of oocytes retrieved |  | up to 38 h after hCG administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, hCG, oocyte retrieval, time interval