Transfer of Frozen Embryos in Natural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate

Study Overview
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Brief Summary
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The purpose of the study is to evaluated whether there is a difference in pregnancy rate when transferring frozen embryos between patietns having spontaneously ovulated versus those triggered to voulate with HCG.

Official Title
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Transfer of Frozen Embryos in NATural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate - Bicentric Prospective Open Randomized Controlled Trial

Conditions
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in Vitro Fertilization

Intervention / Treatment
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* Other: HCG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan The patient is aged between 18 and 40 Patient has regular cycles and classified as 'easy' for transfer of a frozen embryo at blastocyste stage (vitrification day 5) Exclusion Criteria: The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study The subject refuses to sign the consent It is impossible to give the subject informed information The patient is under safeguard of justice or state guardianship Patient using donated oocytes Necessity of pre-implantation diagnosis Patients with stage 3 or 4 endometriosis or adenomyosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: human chorionic gonadotropin (HCG)<br>Ovulation triggered using HCG: choriogonadotropin alpha (Ovitrelle, Merck Serono), 250 μg/0.5ml | Other: HCG<br>* 250 μg/0.5ml choriogonadotropine alpha, Ovitrelle, Merck Serono<br>|
| No Intervention: spontaneous<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate after transfer of frozen embryos at day 14 between groups | Yes/no; Blood ßHCG > 100UI/L | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate at week 12 | Yes/no; ultrasound | Week 12 | 
| Miscarriage rate within first 12 weeks | Yes/no; ultrasound | Week 12 | 
| Live birth | Yes/no | At delivery, maximum week 42 | 
| Pregnancy term | Weeks | At delivery, maximum week 42 | 
| Birth weight | Kg | At delivery, maximum week 42 | 
| Cancellation of transfer due to premature ovulation (progesterone >3ng/ml and/or Luteinizing hormone > 3-fold base level) | Yes/no | Day 0 | 
| Number of visits for endometrial preparation until attaining LH peak | Number of visits | Day 0 |