Down-regulated Hormonally Controlled Cycles for Vitrification-warmed Blastocyst Transfers

Pregnancy Clinical Trial

Official title:

Down-regulated Hormonally Controlled Cycles for Vitrification-warmed Blastocyst Transfers: Reduces Time to Transfer and Cycle Cancellation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02238431
• Other study ID #: Lucrin depot FET cycle
• Secondary ID: FET cycle cancel
• Status: Withdrawn
• Phase: N/A
• First received: September 5, 2014
• Last updated: May 25, 2016
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: Antalya IVF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Currently all patients that have freeze-all ICSI treatment cycles have the start of their FET cycle scheduled with the use of OCP. While an excellent pregnancy rate (75%) for the patients that have a blastocyst transfer has been maintained over time, 15% of started FET cycles are being cancelled because of premature luteinization, and the treatment (to transfer) takes approximately 89 days. The use of a Lucrin depot may reduce the number of cycles cancelled and reduce the treatment time to approximately 69 days. The use of no drugs and allowing the normal menstrual cycle to determine the time to start the FET cycle may suit some patients. Whether these benefits can be obtained while still maintaining the current FET pregnancy rate will be the main focus of the trial.

Description:

The patients will undergo standard assisted conception procedures; controlled ovarian stimulation (COS), oocyte pickup procedure (OPU), ICSI, embryo culture, blastocyst vitrification and frozen embryo transfer. If sufficient (>2) viable blastocyst develop from the in vitro culture of their embryos, all viable blastocysts will be cryopreserved using a routine vitrification procedure. This is the eligible patient population. On the day the last blastocyst(s) are frozen the patients will be given a further opportunity to ask questions and if satisfied they will be asked to complete a trial consent. At this point patients will be randomized by numeric code and given a schedule and drug prescription for scheduling the start of their hormone supplemented frozen embryo transfer cycle. During the scheduling period the patients will follow the drug prescription provided . After the completion of their treatment - the transfer of one or two vitrified-warmed blastocyst - the patients from both groups will receive identical luteal support drug schedules and prescriptions. A blood test will be performed on the 15th day of progesterone supplementation, to determine the βhCG blood concentration. Currently at Antalya IVF, approximately 75% of patients who have blastocysts transferred in a frozen embryo transfer cycle have a positive biochemical pregnancy test, >29 international units per litre (IU/L) of human chorionic gonadotropin (βhCG). If pregnant, patients will continue using estrogen and progesterone supplementation for a further 8 weeks. At 7 weeks of gestation (5 weeks after embryo transfer ) the patients will receive a transvaginal ultrasound scan (TVUS) to check for pregnancy viability (fetal sac with cardiac activity). Thereafter the patients will have regular TVUS to follow fetal development. At 20 weeks of gestation a TVUS will be performed to confirm an ongoing pregnancy (normal fetal development).

All drug packs are delivered to the clinic by the pharmacy after receiving the prescription. A staff member will verify the code on the prescription with randomization code allocated to the patient. The pack will then be given to the patient after verbally confirming patient identity. The packs will also contain a drug use instruction sheet and a trial information sheet.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 42 Years

Eligibility

Inclusion Criteria:

• If patients have >2 blastocysts vitrified

Exclusion Criteria:

• All patients not willing to participate in the study

• Patients with any known adverse reaction to one or the other of the drugs prescribed

• All patients that have no surviving blastocysts for transfer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Lucrin depot
scheduling the start of the artificial cycle and hormone down regulation during the artificial cycle
• OCP
to schedule the start of the artificial cycle

Other:
• Natural
to use the normal menstrual period to schedule treatment start

Locations

Country	Name	City	State
Turkey	Antalya IVF	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya IVF

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Gelbaya TA, Nardo LG, Hunter HR, Fitzgerald CT, Horne G, Pease EE, Brison DR, Lieberman BA. Cryopreserved-thawed embryo transfer in natural or down-regulated hormonally controlled cycles: a retrospective study. Fertil Steril. 2006 Mar;85(3):603-9. — View Citation

Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.109 — View Citation

Hill MJ, Miller KA, Frattarelli JL. A GnRH agonist and exogenous hormone stimulation protocol has a higher live-birth rate than a natural endogenous hormone protocol for frozen-thawed blastocyst-stage embryo transfer cycles: an analysis of 1391 cycles. Fertil Steril. 2010 Feb;93(2):416-22. doi: 10.1016/j.fertnstert.2008.11.027. Epub 2009 Jan 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pregnancy	>29 IU/L ßhCG on day 15 from the start of progesterone supplementation	15 days after start the start of progesterone supplementation	No
Primary	Cycle cancellation	blood progesterone concentration (>2nmol/L) as a measure of premature luteinization	On day 14 of estrogen supplementation	No
Secondary	Ongoing pregnancy rate	TVUS normal fetal development >20 weeks of gestation, in case of a pregnancy	20 weeks of gestation	No