Tri-pH: Triple-arm pH Comparison

Sponsor
Ibn Sina Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02896777
Collaborator
Egyptian IVF Center (Other), Banon IVF Center Assiut, Egypt (Other)
2,273
6
3
35
378.8
10.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6
  • Other: Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6
  • Other: Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
2273 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Triple-arm Trial of pH (Tri-pH) Effect on Live Birth After ICSI
Actual Study Start Date :
Jun 13, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. live-birth rate [> 20 weeks of gestation]

    delivery of one or more viable infants > 20 weeks of gestation

Secondary Outcome Measures

  1. Biochemical pregnancy rate [within 7 weeks of gestation]

    registered positive hCG ≥14 days after egg collection

  2. Clinical pregnancy rate [≥ 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

  3. Ongoing pregnancy rate [within 24 weeks of pregnancy]

    Continued pregnancy after 20 weeks of gestation

  4. Miscarriage rate [within 42 weeks of pregnancy]

    Loss of pregnancy before week 20 of gestation

  5. Term Live birth rate [≥ 37 weeks of gestation]

    Delivery of one or more viable infants ≥ 37 weeks of gestation

  6. Live-birth-implantation rate [within 42 weeks of gestation]

    Number of viable neonates per number of embryos transferred

  7. Cumulative live birth after one fresh and one frozen transfer [within one year from randomization]

    Registered live birth from one fresh and one frozen cycles

  8. Preterm Birth rate [<37 weeks of gestation]

    Delivery of one or more viable infants <37 weeks of gestation

  9. Very preterm birth rate [<32 weeks of gestation]

    Delivery of one or more viable infants <32 weeks of gestation

  10. Still birth [42 weeks after ICSI]

    delivery of nonviable babies > 20 weeks of gestation

  11. Low birth weight babies [24 hours after delivery]

    Viable neonate < 2500 gm within 24 hours of delivery

  12. Congenital malformation [within 42 weeks of gestation]

    delivery of congenitally malformed babies

  13. Fertilisation rate [Within 18 hours of inseminating the oocyte]

    Presence of 2 pronuclei17±1 hr post insemination/ICSI

  14. Cleavage rate [Within 72 hours of inseminating the oocytes]

    registered divided embryo per fertilised oocyte

  15. High quality embryo on day 3 [Within 72 hours of inseminating the oocytes]

    embryo of 7 or more appropriate-size blastomeres with < 10 fragmentation by volume per Istanbul Consensus

  16. Blastocyst formation rate on day 5/6 [Within 5-7 days of inseminating the oocytes]

    Formed blastocyst of any grade on day 5 or 6 per fertilized oocyte

  17. High-quality blastocyst rate on day 5 [5 Days of inseminating the oocytes]

    Blastocyst of ≥ 3.1.1.grading per Istanbul Consensus on day 5

  18. Cryopreservation rate on day 5/6 [5-7 Days of inseminating the oocytes]

    Number of cryopreserved blastocyst on day 5 and 6 per fertilized oocyte

  19. Embryo utilization rate [5-7 days post ICSI]

    Embryo Utilization rate (number of cryopreserved embryos added to the transferred embryos per fertilized oocytes

  20. Top-quality embryo utilization rate [5-7 days post ICSI]

    number of cryopreserved embryos added to the transferred embryos per fertilized oocytes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 (8-12) 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banon Assiut Assiut Egypt
2 Egyptian IVF-ET Center Cairo Egypt
3 Royal Centre Mansoura Egypt 123456
4 Qena Fertility Center Qena Egypt 123456
5 Amshaj Sohag Egypt 12345
6 IbnSina IVF Center Sohag Egypt

Sponsors and Collaborators

  • Ibn Sina Hospital
  • Egyptian IVF Center
  • Banon IVF Center Assiut, Egypt

Investigators

  • Principal Investigator: Mohamed Fawzy, Ibnsina Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier:
NCT02896777
Other Study ID Numbers:
  • pH Study
First Posted:
Sep 12, 2016
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital

Study Results

No Results Posted as of Aug 16, 2022