Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs

Comparison of the Effectiveness of Micronized Vaginal Progesterone (Endometrin, Ferring) Vs. Progesterone in Oil for Luteal Phase Support in Donor Egg Recipient IVF Cycles Utilizing Previously Vitrified Donor Oocytes

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01465373

Enrollment

Registered

2011-11-04

Start date

2010-02-28

Completion date

2011-09-30

Last updated

2011-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

In-Vitro Fertilization, Donor Egg IVF

Brief summary

The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.

Detailed description

The primary objective of this study is to evaluate the clinical pregnancy rate of micronized progesterone (Endometrin, Ferring Pharmaceuticals) compared to progesterone in oil injections in in-vitro fertilization (IVF) donor egg recipients. The secondary objective is to evaluate the effectiveness of freezing/vitrification of donor eggs. Effectiveness of vitrification will be evaluated by egg thaw/survival, fertilization, and implantation rates.

Interventions

DRUGEndometrin

100 mg per vagina TID

DRUGProgesterone in Oil

50 mg IM injection daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 49 Years

Healthy volunteers

Yes

Inclusion criteria

Oocyte Donors: * Age 21-34 years of age * BMI 18-34 * Normal ovarian reserve, defined as FSH \<10 and AFC \>10 * Medical evaluation consistent with FDA criteria for donor inclusion Donor Oocyte Recipients * Documented history of infertility requiring donor oocyte for optimal fertility potential * Documentation of a normal uterine cavity by hysteroscopy, hysterosonogram, or HSG within 1 year of study screening * Fresh or Frozen Sperm

Exclusion criteria

Oocyte Donors: * Abnormal ovarian reserve, defined as FSH \<10, AFC\>10, prior poor response to controlled ovarian hyper-stimulation(COHS) * Failure to meet FDA criteria for donor approval (risk factor and medical evaluation) * Previous history of poor response to COHS Donor Oocyte Recipients: * Uncontrolled hypothyroidism, hyperprolactinemia, or systemic disease that may interfere with study treatment * Active thrombophlebitis or thromboembolic disorders, or a history of hormone associated thrombophlebitis or thromboembolic disorders * Surgically aspirated sperm (TESE) * 2 or more clinical pregnancy losses (excluding aneuploidy for previous autologous cycles) * Clinically significant gynecologic pathology or uterine abnormality, such as submucosal fibroids \> 5 cm, communicating hydrosalpinx, uncorrected uterine septum, undiagnosed vaginal bleeding, endometrial atypia, or any other condition that could adversely affect pregnancy outcomes * History of 2 or more failed IVF donor cycles

Design outcomes

Primary

Measure	Time frame
Clinical pregnancy rate of micronized vaginal progesterone (Endometrin, Ferring Pharmaceuticals) compared to intramuscular progesterone supplementation for luteal phase support after IVF-ET from previously vitrified donor eggs	10-12 days post IVF-ET

Secondary

Measure	Time frame
Evaluation of the effectiveness of vitrification of IVF donor oocytes. Effectiveness will be evaluated by ooctye thaw/survival rates, fertilization and implantation rates assessed from the day of oocyte thawing through IVF cycle outcome.	six to eight weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026