Ovarian Hyperstimulation Syndrome (OHSS) MedDRA version: 14.0 Level: PT Classification code 10033266 Term: Ovarian hyperstimulation syndrome System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: Progynova
Pharmaceutical Form: Tablet
CAS Number: 979-32-8
Other descriptive name: ESTRADIOL VALERATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Sponsors
IVI Madrid
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 34 years old. 2.Ovule donors admitted in the IVI Oocyte Donor Program - Madrid. 3.Conventional ovarian stimulation protocol. 4.Normal XX karyotype. 5.Body mass index (BMI) between 18 and 25 kg / m2. 6.Negative serologies for Hepatitis B surface antigens (HBs Ag), antibodies for the Hepatitis C virus (HC Hb) and Human Immunodeficiency Virus (HIV) prior to donation. 7.Normal cervical cytology in the past year. 8.General informed consent signed by the patients or their legal representative. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Any clinical condition that counterindicates or prevents being able to carry out an endometrial biopsy. 2.Hypersensitivity, allergy or intolerance to any of the medications prescribed in each of the treatment groups. 3.Participation in another clinical trial at the time of donation. 4.Any serious concomitant illness which, according to investigator´s opinion, may compromise the study or affect patients´ tolerability with regard to this treatment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Se recogerán las siguientes variables secundarias: a) Niveles hormonales: Se realizará una evaluación de los niveles de progesterona, estradiol y LH el día de la extracción ovocitaria y su evolución hasta el día LH+7 en el que se realizará la biopsia endometrial en cada uno de los protocolos de soporte de fase lútea. b) Seguridad: Se valorará la proporción de pacientes que han experimentado acontecimientos adversos.;Timepoint(s) of evaluation of this end point: Hormone levels samplings will be performed in three occasions: LH+2, LH+4 y LH+7 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to evaluate the influence of different therapeutic strategies during the luteal phase (steroids, recombinant LH, hCG at low doses) in endometrial receptivity, in patients at high risk of ovarian hyperstimulation in whom ovulation induction with aGnRH is decided.;Secondary Objective: 1.To evaluate the influence in hormonal levels of such supporting strategies during the luteal phase. 2.To evaluate the safety of study medication administered in this patient population. 3.To obtain a usable protocol in patients at high risk of ovarian hyperstimulation in whom ovulation induction with aGnRH is decided.;Primary end point(s): The primary efficacy variable will be the evaluation of endometrial receptivity, measured by endometrial microarrays (ERA) tool in each one of the 4 supportive protocols of the luteal phase, compared with the stardard protocol in which the final oocyte maturation will be induced with 250 mcg of hCG . This tool provides a comparison of the genetic expression associated with endometrial receptivity, expressed in two different groups: "R" (Receptive) and "IF" (Implantation Failure). These results indicate a high (R) or low (IF) probability of successs with regard to embryonic implantation in the following cycle with ovarian stimulation.;Timepoint(s) of evaluation of this end point: From the primary endpoint analysis, the percentages of patients in each group with regard to a high or low probability of success concerning embryonic implantation, will be recorded and compared. | — |
Countries
Spain
Contacts
Public ContactIVI Madrid
IVI Madrid
Outcome results
None listed