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Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for IntracytoplasmicSperm Injection Outcome

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ClinicalTrials.gov Identifier: NCT03105323
Recruitment Status : Not yet recruiting
First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
ahmed nasr ali etman, Ain Shams Maternity Hospital

Brief Summary:

This study will be conducted at the In vitro fertilization Unit at Ain Shams University Maternity Hospital.

Women will be recruited from the In vitro fertilization Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study The study will assess Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for Intracytoplasmic Sperm Injection outcome.


Condition or disease
Infertility, Female

Detailed Description:

Blood samples were collected on the day of final oocyte maturation, and serum Progesterone levels were measured using a chemiluminescent immunoassay for quantitative determination of the hormone .

The P/F ratio was calculated according to the equation (P(ng/mL)/number of follicles) and was defined by the measurements obtained on the day of final oocyte maturation.

All ultrasounds were performed at our In vitro fertilization center, and we included the number of follicles ≥14mm on the day of final oocyte maturation in the ratio calculation Oocytes were retrieved 36 hours after injection and were subsequently fertilized by In vitro fertilization or Intra cytoplasmic sperm injection. On day 2 - 5, all embryos were evaluated for cell number and morphology.

Each embryo transferred was evaluated for blastomere size and fragmentation. Embryos were graded as follows. Those with equal blastomere size and no fragmentation were considered Grade 1; those with blastomeres of equal size with slight fragmentation (<20 %) were Grade 2;those with blastomeres of unequal size but no fragmentation were Grade 3; those with blastomeres of equal or unequal size and moderate fragmentation (20 %-50 %) were Grade 4; and those with unrecognizable blastomeres and severe fragmentation (>50 %) were Grade 5.

The embryos were transferred on postretrieval day (2 - 5). Pregnancy was defined by Human chorionic gonadotropin titers within 11 days following Embryo transfer. Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation.


Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for IntracytoplasmicSperm Injection Outcome
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
infertile women
All patients were pretreated with Gonadotropin releasing hormone agonist (decapeptyl®) 0.05 mg/day from 10 days prior to the start of menstruation. The patients'ovaries were stimulated with a recombinant follicle-stimulating hormone (FSH, subcutaneous) from day 2 of the menstrual cycle. human chorionic gonadotropin was administered when at least two follicles vary 18-22mm were observed on ultrasonography.Blood samples were collected on the day of final Human chorionic gonadotropin maturation, and serum P levels were measured.Pregnancy was defined by titers within 11 days following Embryo transfer,Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation.



Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: a year ]
    rate of incidence of pregnancy after Intracytoplasmic Sperm Injection



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This study will be conducted at the IVF Unit at Ain Shams University Maternity Hospital.

Women will be recruited from the IVF Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

Criteria

Inclusion Criteria:

  1. Women with any type of subfertility undergoing IVF treatment.
  2. Age between (20-40) years old
  3. Body mass index between (20-40)
  4. Selected embryo are of grade 1 and 2 quality.

Exclusion Criteria:

  1. Age above 40 years old
  2. BMI above 40
  3. Bad quality embryo
  4. Uterine anomalies or malformation that affect embryo transfer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105323


Contacts
Contact: Ahmed Hashad 01006332360 ext 02 a7mednasr@live.com
Contact: Mohamed Daoud 01006332360 ext 02 a7mednasr@live.com

Sponsors and Collaborators
Ain Shams Maternity Hospital

Responsible Party: ahmed nasr ali etman, Resident of Obstetrics and gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03105323     History of Changes
Other Study ID Numbers: ain shams university
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs