Triple-arm pH Comparison (Tri-pH)

August 16, 2023 updated by: Muhammad Fawzy, Ibn Sina Hospital

Triple-arm Trial of pH (Tri-pH) Effect on Live Birth After ICSI

The culturing human embryo in vitro is a process of myriad contributing elements. From these factors is the pH of embryo culture media, which is crucial for embryo development. The investigators plan to examine three different pH values of the culture media on the live birth rate of in vitro cultured human embryos.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In vitro fertilisation laboratory is the black box in which early human embryo development of infertile couple occurs. This laboratory holds many variables such as incubator type, air quality, brands of culture media, culture temperature and the pH of culture medium. Despite the importance of the culture medium pH, there is no single RCT has examined its effect on live birth rate post in vitro fertilisation. The investigators of this study believe that leaving this crucial element to the wishes of large companies and media designers is unwise. This RCT aims to provide a conclusive answer on pH effect on live birth rate of in vitro cultured human embryos.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2273

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Banon Assiut
      • Cairo, Egypt
        • Egyptian IVF-ET Center
      • Mansoura, Egypt, 123456
        • Royal Centre
      • Qena, Egypt, 123456
        • Qena Fertility Center
      • Sohag, Egypt
        • IbnSina IVF Center
      • Sohag, Egypt, 12345
        • Amshaj

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women age of ≥ 18 to ≤ 40
  2. BMI of ≤ 35 (After approval of the DMC on 19 Feb 2021 and the IRB thereafter, BMI is changed from ≤31 to ≤35 based on clinician request. DMC).
  3. Normal responder (≥ 10 antral follicle count (AFC) during basal ultrasound examination)
  4. PCOS
  5. Women who have ≥ 1 year of primary or secondary infertility
  6. Tubal factor (unilateral, bilateral obstruction or salpingectomy)
  7. Normal semen parameters
  8. Male factor: oligoasthenozoospermia or obstructive azoospermia
  9. Women who are undergoing their first IVF or ICSI cycle or second IVF Cycle with previous successful attempt
  10. Women who will undergo only fresh embryo transfer
  11. Women who have normal endometrial thickness (> 7 mm) and echo-pattern at the time of hCG trigger
  12. Women who have normal transvaginal ultrasound during the follicular phase (defined as no intra cavity pathology; e.g. submucousal myomas, polyps or septa)

Exclusion Criteria:

  1. Women who had unilateral oophorectomy
  2. Women who had uterine pathology or abnormality
  3. Women or their husbands who had abnormal karyotyping
  4. Women with history of recurrent abortions or repeated implantation failures
  5. Women who had uncontrolled diabetes
  6. Women with diagnosed or undiagnosed liver or renal disease
  7. Women who had a history of severe ovarian hyperstimulation
  8. Women who had history of malignancy or borderline pathology
  9. Women who will not meet the inclusion criteria
  10. Women who will refuse to participate in the study
  11. Women with endometriosis
  12. Patient undergoing PGS or PGD
  13. Severe male factor and non-obstructive azoospermia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transfer embryos from 7.20±0.02 pH
In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.2±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI.
Other: Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6
Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.20±0.02.
Experimental: Transfer embryos from 7.3±0.02 pH
In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.3±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI.
Other: Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6
Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.3±0.02.
Experimental: Transfer embryo from 7.4±0.02
In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.4±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI.
Other: Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6
Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.4±0.02 from day 0 to 5/6

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
live-birth rate
Time Frame: > 20 weeks of gestation
delivery of one or more viable infants > 20 weeks of gestation
> 20 weeks of gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemical pregnancy rate
Time Frame: within 7 weeks of gestation
registered positive hCG ≥14 days after egg collection
within 7 weeks of gestation
Clinical pregnancy rate
Time Frame: ≥ 7 weeks of gestation
presence of a foetal sac with a foetal heart beat on ultrasound > 7 weeks of presence of a foetal sac with a foetal heart beat on ultrasound > 7 weeks of gestation
≥ 7 weeks of gestation
Ongoing pregnancy rate
Time Frame: within 24 weeks of pregnancy
Continued pregnancy after 20 weeks of gestation
within 24 weeks of pregnancy
Miscarriage rate
Time Frame: within 42 weeks of pregnancy
Loss of pregnancy before week 20 of gestation
within 42 weeks of pregnancy
Term Live birth rate
Time Frame: ≥ 37 weeks of gestation
Delivery of one or more viable infants ≥ 37 weeks of gestation
≥ 37 weeks of gestation
Live-birth-implantation rate
Time Frame: within 42 weeks of gestation
Number of viable neonates per number of embryos transferred
within 42 weeks of gestation
Cumulative live birth after one fresh and one frozen transfer
Time Frame: within one year from randomization
Registered live birth from one fresh and one frozen cycles
within one year from randomization
Preterm Birth rate
Time Frame: <37 weeks of gestation
Delivery of one or more viable infants <37 weeks of gestation
<37 weeks of gestation
Very preterm birth rate
Time Frame: <32 weeks of gestation
Delivery of one or more viable infants <32 weeks of gestation
<32 weeks of gestation
Still birth
Time Frame: 42 weeks after ICSI
delivery of nonviable babies > 20 weeks of gestation
42 weeks after ICSI
Low birth weight babies
Time Frame: 24 hours after delivery
Viable neonate < 2500 gm within 24 hours of delivery
24 hours after delivery
Congenital malformation
Time Frame: within 42 weeks of gestation
delivery of congenitally malformed babies
within 42 weeks of gestation
Fertilisation rate
Time Frame: Within 18 hours of inseminating the oocyte
Presence of 2 pronuclei17±1 hr post insemination/ICSI
Within 18 hours of inseminating the oocyte
Cleavage rate
Time Frame: Within 72 hours of inseminating the oocytes
registered divided embryo per fertilised oocyte
Within 72 hours of inseminating the oocytes
High quality embryo on day 3
Time Frame: Within 72 hours of inseminating the oocytes
embryo of 7 or more appropriate-size blastomeres with < 10 fragmentation by volume per Istanbul Consensus
Within 72 hours of inseminating the oocytes
Blastocyst formation rate on day 5/6
Time Frame: Within 5-7 days of inseminating the oocytes
Formed blastocyst of any grade on day 5 or 6 per fertilized oocyte
Within 5-7 days of inseminating the oocytes
High-quality blastocyst rate on day 5
Time Frame: 5 Days of inseminating the oocytes
Blastocyst of ≥ 3.1.1.grading per Istanbul Consensus on day 5
5 Days of inseminating the oocytes
Cryopreservation rate on day 5/6
Time Frame: 5-7 Days of inseminating the oocytes
Number of cryopreserved blastocyst on day 5 and 6 per fertilized oocyte
5-7 Days of inseminating the oocytes
Embryo utilization rate
Time Frame: 5-7 days post ICSI
Embryo Utilization rate (number of cryopreserved embryos added to the transferred embryos per fertilized oocytes
5-7 days post ICSI
Top-quality embryo utilization rate
Time Frame: 5-7 days post ICSI
number of cryopreserved embryos added to the transferred embryos per fertilized oocytes
5-7 days post ICSI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ibn Sina Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Banon IVF Center Assiut, Egypt
Egyptian IVF Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed Fawzy, Ibnsina Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pH Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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