Second Step Protocol in Poor Ovarian Responder (POR)

NCT03480412 | Unknown

• 1 other identifier: Second Step 1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Reduced ovarian reserve and the consequent poor ovarian response are very recurent in infertile patients, indeed a percentage of 10%-24% of couples addressed to infertility program may be classified as Poor Ovarian Responder (POR). Objective: To evaluate whether the repeated luteal phase stimulation (Second Step) permits a significantly higher number of oocytes retrieved in POR when compared to conventional follicular stimulation. Interventions: The follicular phase stimulation is conduced according to a standardized Antagonist protocol or Short protocol (with GnRH agonist) using recombinant or urinary gonadotropins (starting dose 300 or 450 UI) or a long lasting recombinant gonadotropin (Corifollitropin alfa 150 mcg). Two - six days after the first oocyte retrieval a second gonadotropin stimulation will be started with a GnRH antagonist protocol (the stimulation will be started with 250 UI of human menopausal gonadotropin (hMG) and a GnRH antagonist (GnRH-an) 0,25 mg\\die will be administered when the leading follicle is ≥ 14 mm until hCG (human chorionic gonadotropin) criteria are met. When at least two follicles had reached 17-18 mm in diameter, ovulation will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin (10.000 UI ) and oocyte retrieval will be performed after 35 hours. Two or Three months after the second oocyte retrieval the Embryo transfer (ET) will be performed after endometrial preparation with Estradiol Valerate and intramuscular Progesterone.

Conditions

Infertility, Female; Premature Ovarian Failure; Fertility Disorders

Keywords

Luteal Phase Stimulation; Poor Ovarian Response; In Vitro Fertilization

Outcome Measures

Primary Outcomes (1)

• Number of oocyte Retrieved

  Number of oocyte Retrieved after the first oocyte retrieval vs Number of oocyte Retrieved after the second oocyte retrieval

  15 days after the Second oocyte retrieval

Secondary Outcomes (1)

• Number of Embryos Obtained

  15 days after the Second oocyte retrieval

Study Arms (2)

Follicular Phase

Procedure: Follicular Phase

Luteal Phase

Procedure: Luteal Phase

Interventions

Follicular Phase PROCEDURE

The follicular phase stimulation is conduced according to a standardized Antagonist protocol or Short protocol (with GnRH agonist) using recombinant or urinary gonadotropins (starting dose 300 or 450 UI) or a long lasting recombinant gonadotropin (Corifollitropin alfa 150 mcg) from the second day of the menstrual cycle. When at least two follicles had reached 17-18 mm in diameter, ovulation will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin (10.000 UI ) and oocyte retrieval will be performed after 35 hours.

Also known as: First Step

Follicular Phase

Luteal Phase PROCEDURE

Two - six days after the first oocyte retrieval a second gonadotropin stimulation will be started with a GnRH antagonist protocol (the stimulation will be started with 250 UI of human menopausal gonadotropin (hMG) and a GnRH antagonist (GnRH-an) 0,25 mg\\die will be administered when the leading follicle is ≥ 14 mm until hCG criteria are met). When at least two follicles had reached 17-18 mm in diameter, ovulation will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin (10.000 UI ) and oocyte retrieval will be performed after 35 hours.

Also known as: Second Step

Luteal Phase

Eligibility Criteria

• Gender Eligibility Details: Women classified like Poor Ovarian Responder
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infertil Women classified as Poor Ovarian Responder according with Bologna Criteria (2011) for which an IVF is indicated and in which the number of oocyte retrieved with First oocyte retrieval ≤ 2

You may qualify if:

• Antral Follicular Count ≤7 follicles
• Number of oocyte retrieved with First oocyte retrieval ≤ 2

You may not qualify if:

• Antral follicular Count \< 7
• Anti-Müllerian hormone (AMH) \>1.1 ng \\mL
• Number of oocyte retrieved with First oocyte retrieval \> 2
• Absence of antral follicles after First oocyte retrieval

Sponsors & Collaborators

• Università degli Studi 'G. d'Annunzio' Chieti e Pescara: lead

Study Sites (1)

Ospedale G. Bernabeo

Ortona, Chieti, 66026, Italy

RECRUITING

MeSH Terms

Conditions

Infertility, Female; Primary Ovarian Insufficiency

Interventions

Follicular Phase; Luteal Phase

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Menstrual Cycle; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Central Study Contacts

Antonia Iacovelli, Doctor

CONTACT

+393203595229; antonia.iacovelli.med@gmail.com

Gian Mario Tiboni, Professor

CONTACT

+393478787545; tiboni@unich.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: September 1, 2017
• Primary Completion: March 30, 2019
• Study Completion: September 1, 2019
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

IT (1)