Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.

Study Overview
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Brief Summary
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Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG.

Official Title
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SHOview Observational Study. Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.

Conditions
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Ovarian Hyperstimulation Syndrome (OHSS)

Intervention / Treatment
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* Other: Highly purified menotropin (HP- hMG) treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who present infertility of more than one year and are candidates for a first or second IVF cycle with or without ICSI for whom HP-hMG is prescribed for COS. Absence of infertility treatment during the last 3 months before enrolment. Age: from 18 to 36 years old. BMI between 18 and 30 kg / m². Presence of both ovaries accessible to puncture and absence of ovarian or uterine abnormalities. Male or female infertility. Ovarian stimulation by HP-hMG with pituitary desensitization by a GnRH agonist or antagonist. Normal ovarian reserve according to physician habitual evaluation. Consent to participate of the no-interventional study and signature of the patients' information sheet. Exclusion Criteria: Presence of a chronic disease, cancer or endocrine disease that could potentially influence the results of the stimulation or that represents a contraindication for ovarian stimulation. Known endometriosis grade III or IV. Contraindication to the use of gonadotropins or current pregnancy diagnosed by the clinician. Recurrent miscarriages, known genetic disease of one of the partners or indication of a preimplantation genetic diagnosis (PGD). Smoking over than 10 cigarettes / day.´ Participation in an interventional study at the time of inclusion. Known poor ovarian response in a previous cycle of stimulation (number of oocyte collected ≤ 3, and / or more than 2 previous IVF/ICSI cycles and / or abnormal result in ovarian reserve test (AMH < 1 ng/ml with Immunotech equipment or AMH<0.7 ng/ml with DSL equipment).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Highly purified menotropin (HP-hMG) treatment<br>Cohort of women from 18 to 36 years old treated by HP-hMG for controlled ovarian stimulation (COS) for a first or second cycle of IVF / ICSI. | Other: Highly purified menotropin (HP- hMG) treatment<br>* No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of moderate/severe OHSS |  | 2-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of each form of OHSS: mild, moderate and severe |  | 2-13 weeks | 
| Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol |  | 2-13 weeks | 
| OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification |  | 2-13 weeks | 
| Patients' baseline characteristics |  | At baseline | 
| Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation |  | Up to 3 weeks | 
| Description and duration of hospitalisation, treatments prescribed |  | 2-13 weeks | 
| Frequency and reasons for stimulation arrest and no embryo transfer decision |  | 2-4 weeks | 
| Number of oocytes retrieved, number of mature oocytes, fertilization rate, embryo quality, embryo freezing, number and quality of transferred embryos |  | 2-3 weeks | 
| Description of serious and not serious adverse events |  | 2-13 weeks | 
| Description of patient's compliance to the prescribed treatment |  | 2-4 weeks | 
| Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate |  | 4-13 weeks |