INTEnsity of ovariaN Stimulation and Embryo Quality

Phase 1

• Conditions: To compare the number of GQB and the morphokinetic parameters of early embryo development in infertile suboptimal patients undergoing two different intensities of ovarian stimulation, a milder approach ( Clomiphene Citrate (CC) 50mg/day plus 150IU daily dose of rFSH) and a more intense approach (300IU daily dose of rFSH).; MedDRA version: 20.0Level: PTClassification code 10021928Term: Infertility femaleSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 21.0Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 20.0Level: LLTClassification code 10021930Term: Infertility NOSSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 20.0Level: PTClassification code 10021929Term: Infertility maleSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 20.1Level: LLTClassification code 10016399Term: Female infertility (primary)System Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 21.1Level: LLTClassification code 10039843Term: Secondary infertility (female)System Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2021-000941-42-ES
• Lead Sponsor: Fundacion Santiago Dexeus Font

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-11
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

•AFC = 5 and = 10
•AMH =1.5 ng/ml (AMH result of up to one year will be valid)
•Age = 35 years and =40 years
•BMI >=18.5 and <25 kg/m2
•Willing to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•AFC >10
•History of untreated autoimmune, endocrine or metabolic disorders
•Contraindication for hormonal treatment
•Preimplantation genetic diagnosis
•Severe male factor (sperm concentration <5M/mL)
•Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication of being pregnant).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the two stimulation groups of Clomiphene Citrate (CC) 50mg/day plus rFSH 150IU vs. 300IU regarding the number of GQB according to the Istanbul Consensus criteria;Secondary Objective: To compare the two stimulation groups of Clomiphene Citrate (CC) 50mg/day plus rFSH 150IU vs. 300IU regarding the morphokinetic parameters of early embryo development;Primary end point(s): The primary efficacy endpoint is the number of GQB, according to the Istanbul Consensus Criteria .;Timepoint(s) of evaluation of this end point: 5-7 days from oocytes insemination procedure

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The key secondary endpoints are: <br>1.Time of pronuclei appearance<br>2.Time of pronuclei disappearance<br>3.The total number of embryos<br>4.Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8)<br>5.Time of compactation<br>6.Time of morula<br>7.Time of cavitation/early blast<br>8.Time of full blastulation<br>9.Time of expanded blastocyst <br>10.Time of hatching blastocyst<br>11.Blastocyst formation rate<br>12. Cycle cancelation rate;Timepoint(s) of evaluation of this end point: 1-7 days from oocytes insemination procedure