Establishing a Biologic Specimens Repository for Reproductive Clinical Trials: Technical Aspects

Figures & data

Table 1.  RMN studies, their primary hypothesis, and biorepository specimens to be collected.

Title	Primary Hypothesis/Resources	Biorepository Specimens
Pregnancy in Polycystic Ovary Syndrome II (PPCOS II)	Ovulation induction with an aromatase inhibitor is more likely to result in live birth then ovulation induction with a selective estrogen modulator in infertile women with polycystic ovary syndrome.	Blood Spot Cardsbreak;Blood Clotbreak;Whole Bloodbreak;Serum
Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation (AMIGOS)	In infertile ovulatory women undergoing ovarian stimulation and intrauterine insemination, the use of aromatase inhibitors will stimulate the ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly reducing the numbers of multiple gestation pregnancies that result from stimulation with clomiphene citrate or follicle stimulating hormone.	Blood Spot Cardsbreak;Blood Clotbreak;Whole Bloodbreak;Serumbreak;Semen
RMN Pregnancy Registry	A registry of babies born as a result of clinical trials of the RMN.	Additional blood spots of baby,break;Saliva sample of father

Table 2.  Samples Collection and Storage Parameters.

Sample	Collection	Storage	Storage Temperature
Whole blood	Purple top (EDTA) vacutainer	Cryovial	−80°C
Whole blood	Purple top (EDTA) vacutainer	FTA collection card	−20°C
Blood Clot	Red top (silica) vacutainer	Cryovial	−80°C
Serum	Red top (silica) vacutainer	Cryovial	−80°C
Saliva	Swab/Oragene® vial	Oragene® vial	−20°C
Sperm	Cup	Cryovial – IVF freezing media	−190°C